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olaparib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| poly-ADP-ribose polymerase inhibitors | 4907 | 763113-22-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.60 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Hosey CM, Chan R, Benet LZ |
| S (Water solubility) | 0.10 mg/mL | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.413 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 25.410 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 13.183 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 4.345 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 38.250 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 51.780 | % | High | 1 |
| herg | hERG pIC50 | 4.517 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.146 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 42.954 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 22.070 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PRKDC | 16 | |||
| kinase-selectivity-class | AXL,GRK2 | 2 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 25.645 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 19.543 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 45.394 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 32.170 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 45.920 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 56.690 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.012 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 25.823 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 79.780 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 32.270 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 864.968 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 19, 2018 | PMDA | AstraZeneca KK | |
| Dec. 19, 2014 | FDA | ASTRAZENECA PHARMS | |
| Oct. 23, 2014 | EMA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 2634.20 | 25.58 | 904 | 15159 | 105966 | 90506418 |
| Anaemia | 1563.18 | 25.58 | 892 | 15171 | 351910 | 90260474 |
| Myelodysplastic syndrome | 1406.39 | 25.58 | 384 | 15679 | 20519 | 90591865 |
| Death | 1097.68 | 25.58 | 786 | 15277 | 455765 | 90156619 |
| Acute myeloid leukaemia | 914.57 | 25.58 | 274 | 15789 | 20366 | 90592018 |
| Ovarian cancer recurrent | 913.17 | 25.58 | 169 | 15894 | 1421 | 90610963 |
| Myelosuppression | 839.30 | 25.58 | 326 | 15737 | 53265 | 90559119 |
| Interstitial lung disease | 602.22 | 25.58 | 286 | 15777 | 76119 | 90536265 |
| Carbohydrate antigen 125 increased | 344.90 | 25.58 | 86 | 15977 | 3180 | 90609204 |
| Disease progression | 335.44 | 25.58 | 253 | 15810 | 156362 | 90456022 |
| Haematotoxicity | 333.59 | 25.58 | 113 | 15950 | 12422 | 90599962 |
| Pancytopenia | 276.86 | 25.58 | 203 | 15860 | 120060 | 90492324 |
| Neutrophil count decreased | 253.93 | 25.58 | 158 | 15905 | 71374 | 90541010 |
| Tumour marker increased | 247.85 | 25.58 | 75 | 15988 | 5732 | 90606652 |
| Renal impairment | 227.00 | 25.58 | 171 | 15892 | 105250 | 90507134 |
| Nausea | 201.51 | 25.58 | 536 | 15527 | 1109780 | 89502604 |
| Platelet count decreased | 197.65 | 25.58 | 176 | 15887 | 136793 | 90475591 |
| Metastases to liver | 193.97 | 25.58 | 97 | 15966 | 28710 | 90583674 |
| Metastases to peritoneum | 191.73 | 25.58 | 57 | 16006 | 4098 | 90608286 |
| Thrombocytopenia | 158.62 | 25.58 | 190 | 15873 | 208535 | 90403849 |
| Metastases to lymph nodes | 137.43 | 25.58 | 58 | 16005 | 11631 | 90600753 |
| Metastases to central nervous system | 132.80 | 25.58 | 64 | 15999 | 17478 | 90594906 |
| Leukaemia | 132.75 | 25.58 | 45 | 16018 | 4947 | 90607437 |
| Metastases to bone | 120.99 | 25.58 | 68 | 15995 | 25437 | 90586947 |
| Second primary malignancy | 100.77 | 25.58 | 45 | 16018 | 10333 | 90602051 |
| Metastasis | 94.62 | 25.58 | 37 | 16026 | 6100 | 90606284 |
| Pneumonitis | 93.50 | 25.58 | 71 | 15992 | 44099 | 90568285 |
| Ileus | 89.17 | 25.58 | 48 | 16015 | 16498 | 90595886 |
| Neuropathy peripheral | 86.85 | 25.58 | 114 | 15949 | 136856 | 90475528 |
| Acute leukaemia | 75.74 | 25.58 | 21 | 16042 | 1175 | 90611209 |
| Acute erythroid leukaemia | 71.93 | 25.58 | 14 | 16049 | 157 | 90612227 |
| Drug resistance | 69.01 | 25.58 | 51 | 16012 | 30398 | 90581986 |
| Ovarian cancer metastatic | 68.20 | 25.58 | 19 | 16044 | 1082 | 90611302 |
| Acquired gene mutation | 65.38 | 25.58 | 19 | 16044 | 1260 | 90611124 |
| Recurrent cancer | 64.72 | 25.58 | 22 | 16041 | 2437 | 90609947 |
| Blood creatinine increased | 63.65 | 25.58 | 84 | 15979 | 101302 | 90511082 |
| Metastases to lung | 60.93 | 25.58 | 37 | 16026 | 15954 | 90596430 |
| Transformation to acute myeloid leukaemia | 60.11 | 25.58 | 14 | 16049 | 385 | 90611999 |
| Bone marrow failure | 59.95 | 25.58 | 48 | 16015 | 32173 | 90580211 |
| Joint swelling | 57.52 | 25.58 | 10 | 16053 | 503290 | 90109094 |
| Neutropenia | 56.81 | 25.58 | 124 | 15939 | 224780 | 90387604 |
| Pain | 54.46 | 25.58 | 58 | 16005 | 996283 | 89616101 |
| BRCA2 gene mutation | 52.79 | 25.58 | 10 | 16053 | 96 | 90612288 |
| Systemic lupus erythematosus | 52.07 | 25.58 | 3 | 16060 | 361893 | 90250491 |
| White blood cell count decreased | 50.23 | 25.58 | 99 | 15964 | 167010 | 90445374 |
| Arthropathy | 49.88 | 25.58 | 4 | 16059 | 366238 | 90246146 |
| Metastases to pleura | 48.80 | 25.58 | 17 | 16046 | 2027 | 90610357 |
| Aplasia pure red cell | 48.76 | 25.58 | 22 | 16041 | 5172 | 90607212 |
| Haemoglobin decreased | 48.75 | 25.58 | 96 | 15967 | 161860 | 90450524 |
| Ascites | 47.34 | 25.58 | 50 | 16013 | 47690 | 90564694 |
| Weight increased | 46.24 | 25.58 | 9 | 16054 | 417918 | 90194466 |
| Acute megakaryocytic leukaemia | 45.69 | 25.58 | 8 | 16055 | 47 | 90612337 |
| Metastases to meninges | 45.45 | 25.58 | 19 | 16044 | 3716 | 90608668 |
| Intestinal obstruction | 44.33 | 25.58 | 43 | 16020 | 37088 | 90575296 |
| BRCA1 gene mutation | 44.24 | 25.58 | 8 | 16055 | 58 | 90612326 |
| Infusion related reaction | 44 | 25.58 | 10 | 16053 | 416770 | 90195614 |
| Sinusitis | 43.42 | 25.58 | 5 | 16058 | 343083 | 90269301 |
| High grade B-cell lymphoma Burkitt-like lymphoma recurrent | 42.70 | 25.58 | 8 | 16055 | 72 | 90612312 |
| Condition aggravated | 41.94 | 25.58 | 27 | 16036 | 595518 | 90016866 |
| Malignant peritoneal neoplasm | 41.74 | 25.58 | 12 | 16051 | 766 | 90611618 |
| Musculoskeletal stiffness | 38.33 | 25.58 | 4 | 16059 | 296528 | 90315856 |
| Breast cancer metastatic | 38.05 | 25.58 | 27 | 16036 | 15105 | 90597279 |
| Therapeutic product effect decreased | 37.87 | 25.58 | 3 | 16060 | 277568 | 90334816 |
| TP53 gene mutation | 37.56 | 25.58 | 7 | 16056 | 61 | 90612323 |
| Pulmonary toxicity | 37.18 | 25.58 | 24 | 16039 | 11507 | 90600877 |
| Nasopharyngitis | 36.98 | 25.58 | 13 | 16050 | 407091 | 90205293 |
| Swelling | 35.39 | 25.58 | 15 | 16048 | 419043 | 90193341 |
| Ovarian cancer | 34.70 | 25.58 | 19 | 16044 | 6748 | 90605636 |
| Pericarditis | 34.01 | 25.58 | 4 | 16059 | 270147 | 90342237 |
| Refractory anaemia with an excess of blasts | 33.76 | 25.58 | 9 | 16054 | 434 | 90611950 |
| Pneumocystis jirovecii pneumonia | 33.55 | 25.58 | 29 | 16034 | 21587 | 90590797 |
| Neoplasm progression | 32.88 | 25.58 | 40 | 16023 | 44446 | 90567938 |
| Drug hypersensitivity | 32.64 | 25.58 | 21 | 16042 | 463588 | 90148796 |
| Rheumatoid arthritis | 32.22 | 25.58 | 12 | 16051 | 362602 | 90249782 |
| Fall | 31.05 | 25.58 | 24 | 16039 | 481786 | 90130598 |
| Mobility decreased | 30.86 | 25.58 | 4 | 16059 | 250730 | 90361654 |
| Malignant ascites | 30.79 | 25.58 | 10 | 16053 | 962 | 90611422 |
| Asthma | 29.48 | 25.58 | 4 | 16059 | 242156 | 90370228 |
| Renal failure | 28.35 | 25.58 | 68 | 15995 | 130939 | 90481445 |
| Erythroblastosis | 28.32 | 25.58 | 4 | 16059 | 3 | 90612381 |
| Disease recurrence | 28.06 | 25.58 | 34 | 16029 | 37619 | 90574765 |
| Myeloid leukaemia | 27.82 | 25.58 | 8 | 16055 | 511 | 90611873 |
| Abdominal discomfort | 26.87 | 25.58 | 27 | 16036 | 477301 | 90135083 |
| Exposure during pregnancy | 26.63 | 25.58 | 5 | 16058 | 238405 | 90373979 |
| Porokeratosis | 26.46 | 25.58 | 6 | 16057 | 146 | 90612238 |
| Fatigue | 26.39 | 25.58 | 316 | 15747 | 1153707 | 89458677 |
| Cytopenia | 26.25 | 25.58 | 23 | 16040 | 17426 | 90594958 |
| Discomfort | 26.24 | 25.58 | 8 | 16055 | 274327 | 90338057 |
| Fibromyalgia | 26.09 | 25.58 | 3 | 16060 | 206266 | 90406118 |
| Acute monocytic leukaemia | 26.01 | 25.58 | 6 | 16057 | 158 | 90612226 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 790.71 | 33.01 | 517 | 3788 | 470668 | 42146362 |
| Malignant neoplasm progression | 588.31 | 33.01 | 262 | 4043 | 108138 | 42508892 |
| Anaemia | 251.27 | 33.01 | 214 | 4091 | 280064 | 42336966 |
| Prostatic specific antigen increased | 222.39 | 33.01 | 78 | 4227 | 16847 | 42600183 |
| Fatigue | 115.47 | 33.01 | 177 | 4128 | 435464 | 42181566 |
| Metastases to bone | 96.43 | 33.01 | 41 | 4264 | 14768 | 42602262 |
| Disease progression | 87.59 | 33.01 | 89 | 4216 | 143567 | 42473463 |
| Nausea | 64.00 | 33.01 | 130 | 4175 | 396669 | 42220361 |
| Metastases to lymph nodes | 61.31 | 33.01 | 23 | 4282 | 5975 | 42611055 |
| Product use issue | 56.87 | 33.01 | 53 | 4252 | 76698 | 42540332 |
| Off label use | 55.72 | 33.01 | 165 | 4140 | 638170 | 41978860 |
| Myelosuppression | 50.95 | 33.01 | 38 | 4267 | 40423 | 42576607 |
| Metastases to liver | 44.68 | 33.01 | 25 | 4280 | 16301 | 42600729 |
| Acquired gene mutation | 44.38 | 33.01 | 13 | 4292 | 1567 | 42615463 |
| Haemoglobin abnormal | 43.43 | 33.01 | 17 | 4288 | 4947 | 42612083 |
| Product use in unapproved indication | 33.85 | 33.01 | 64 | 4241 | 184392 | 42432638 |
| Lymphopenia | 33.44 | 33.01 | 23 | 4282 | 21540 | 42595490 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 1677.11 | 24.70 | 691 | 14349 | 173876 | 110400383 |
| Anaemia | 1438.67 | 24.70 | 899 | 14141 | 546187 | 110028072 |
| Myelodysplastic syndrome | 934.60 | 24.70 | 301 | 14739 | 37183 | 110537076 |
| Acute myeloid leukaemia | 737.91 | 24.70 | 253 | 14787 | 37857 | 110536402 |
| Death | 658.60 | 24.70 | 626 | 14414 | 698243 | 109876016 |
| Myelosuppression | 626.51 | 24.70 | 289 | 14751 | 94051 | 110480208 |
| Ovarian cancer recurrent | 503.82 | 24.70 | 86 | 14954 | 581 | 110573678 |
| Interstitial lung disease | 402.74 | 24.70 | 245 | 14795 | 139089 | 110435170 |
| Nausea | 247.74 | 24.70 | 527 | 14513 | 1235163 | 109339096 |
| Neutrophil count decreased | 212.05 | 24.70 | 156 | 14884 | 120785 | 110453474 |
| Disease progression | 207.96 | 24.70 | 208 | 14832 | 243826 | 110330433 |
| Pancytopenia | 199.78 | 24.70 | 190 | 14850 | 209423 | 110364836 |
| Carbohydrate antigen 125 increased | 184.21 | 24.70 | 47 | 14993 | 2500 | 110571759 |
| Metastases to lymph nodes | 183.08 | 24.70 | 71 | 14969 | 14961 | 110559298 |
| Metastases to liver | 175.70 | 24.70 | 89 | 14951 | 35297 | 110538962 |
| Platelet count decreased | 166.73 | 24.70 | 180 | 14860 | 230263 | 110343996 |
| Metastases to peritoneum | 164.17 | 24.70 | 51 | 14989 | 5559 | 110568700 |
| Metastases to bone | 135.88 | 24.70 | 72 | 14968 | 31300 | 110542959 |
| Thrombocytopenia | 124.54 | 24.70 | 192 | 14848 | 348693 | 110225566 |
| Prostatic specific antigen increased | 117.43 | 24.70 | 49 | 14991 | 12462 | 110561797 |
| Haematotoxicity | 110.43 | 24.70 | 55 | 14985 | 21027 | 110553232 |
| Tumour marker increased | 107.19 | 24.70 | 36 | 15004 | 5024 | 110569235 |
| Fatigue | 98.05 | 24.70 | 374 | 14666 | 1215584 | 109358675 |
| Drug resistance | 94.83 | 24.70 | 71 | 14969 | 56303 | 110517956 |
| Second primary malignancy | 94.23 | 24.70 | 47 | 14993 | 18021 | 110556238 |
| Renal impairment | 92.74 | 24.70 | 121 | 14919 | 188324 | 110385935 |
| Metastases to central nervous system | 92.16 | 24.70 | 50 | 14990 | 22767 | 110551492 |
| Acquired gene mutation | 80.42 | 24.70 | 25 | 15015 | 2729 | 110571530 |
| Acute erythroid leukaemia | 75.53 | 24.70 | 16 | 15024 | 371 | 110573888 |
| Pneumonitis | 72.04 | 24.70 | 69 | 14971 | 76462 | 110497797 |
| Metastasis | 66.40 | 24.70 | 29 | 15011 | 8238 | 110566021 |
| Metastases to lung | 65.01 | 24.70 | 40 | 15000 | 23023 | 110551236 |
| Neuropathy peripheral | 61.50 | 24.70 | 97 | 14943 | 179180 | 110395079 |
| Acute leukaemia | 54.89 | 24.70 | 17 | 15023 | 1832 | 110572427 |
| BRCA2 gene mutation | 54.54 | 24.70 | 10 | 15030 | 106 | 110574153 |
| Metastases to pleura | 53.06 | 24.70 | 17 | 15023 | 2046 | 110572213 |
| White blood cell count decreased | 51.39 | 24.70 | 103 | 14937 | 229287 | 110344972 |
| BRCA1 gene mutation | 51.25 | 24.70 | 9 | 15031 | 73 | 110574186 |
| Transformation to acute myeloid leukaemia | 49.45 | 24.70 | 15 | 15025 | 1508 | 110572751 |
| Neutropenia | 48.72 | 24.70 | 136 | 14904 | 374484 | 110199775 |
| Acute megakaryocytic leukaemia | 46.85 | 24.70 | 8 | 15032 | 54 | 110574205 |
| Ileus | 45.74 | 24.70 | 36 | 15004 | 30693 | 110543566 |
| Lymphopenia | 45.14 | 24.70 | 40 | 15000 | 40130 | 110534129 |
| Ovarian cancer metastatic | 44.69 | 24.70 | 12 | 15028 | 779 | 110573480 |
| High grade B-cell lymphoma Burkitt-like lymphoma recurrent | 44.15 | 24.70 | 8 | 15032 | 79 | 110574180 |
| Bone marrow failure | 41.39 | 24.70 | 45 | 14995 | 57803 | 110516456 |
| Joint swelling | 40.49 | 24.70 | 6 | 15034 | 442839 | 110131420 |
| Decreased appetite | 39.38 | 24.70 | 148 | 14892 | 475698 | 110098561 |
| Metastases to meninges | 38.00 | 24.70 | 17 | 15023 | 5111 | 110569148 |
| Leukaemia | 37.56 | 24.70 | 19 | 15021 | 7499 | 110566760 |
| Pain | 37.42 | 24.70 | 45 | 14995 | 954910 | 109619349 |
| Pneumocystis jirovecii pneumonia | 35.49 | 24.70 | 36 | 15004 | 42699 | 110531560 |
| TP53 gene mutation | 33.22 | 24.70 | 7 | 15033 | 158 | 110574101 |
| Haemoglobin decreased | 32.00 | 24.70 | 90 | 14950 | 248637 | 110325622 |
| Vomiting | 31.73 | 24.70 | 222 | 14818 | 910453 | 109663806 |
| Condition aggravated | 31.65 | 24.70 | 32 | 15008 | 734804 | 109839455 |
| Weight increased | 31.52 | 24.70 | 9 | 15031 | 419635 | 110154624 |
| Musculoskeletal toxicity | 30.79 | 24.70 | 7 | 15033 | 227 | 110574032 |
| Refractory anaemia with an excess of blasts | 30.34 | 24.70 | 9 | 15031 | 838 | 110573421 |
| Pulmonary toxicity | 29.05 | 24.70 | 22 | 15018 | 17724 | 110556535 |
| Intestinal obstruction | 29.01 | 24.70 | 36 | 15004 | 53191 | 110521068 |
| Aplasia pure red cell | 27.98 | 24.70 | 17 | 15023 | 9561 | 110564698 |
| Rheumatoid arthritis | 27.51 | 24.70 | 4 | 15036 | 299609 | 110274650 |
| Malignant peritoneal neoplasm | 26.97 | 24.70 | 8 | 15032 | 745 | 110573514 |
| Nasopharyngitis | 26.90 | 24.70 | 10 | 15030 | 394351 | 110179908 |
| Mechanical ileus | 26.71 | 24.70 | 9 | 15031 | 1268 | 110572991 |
| Haemoglobin abnormal | 26.30 | 24.70 | 16 | 15024 | 9022 | 110565237 |
| Musculoskeletal stiffness | 25.08 | 24.70 | 4 | 15036 | 279818 | 110294441 |
| Sinusitis | 24.95 | 24.70 | 5 | 15035 | 296683 | 110277576 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XK01 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Poly (ADP-ribose) polymerase (PARP) inhibitors |
| MeSH PA | D000067856 | Poly(ADP-ribose) Polymerase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA MoA | N0000191622 | Poly(ADP-Ribose) Polymerase Inhibitors |
| FDA EPC | N0000191623 | Poly(ADP-Ribose) Polymerase Inhibitor |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:62913 | EC 2.4.2.30 (NAD<small><sup>+</small></sup> ADP-ribosyltransferase) inhibitor |
| CHEBI has role | CHEBI:68495 | apoptosis inducer |
Related Drugs by ATC class:
L01XK Poly (ADP-ribose) polymerase (PARP) inhibitors 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Epithelial tumor of ovary | indication | 237057005 | DOID:2152 |
| Malignant tumor of pancreas | indication | 363418001 | |
| Malignant tumor of ovary | indication | 363443007 | DOID:2394 |
| Malignant tumor of peritoneum | indication | 363492001 | |
| Hormone refractory prostate cancer | indication | 427492003 | |
| Human epidermal growth factor 2 negative carcinoma of breast | indication | 431396003 | |
| BRCA positive prostate cancer | indication | 715412008 | |
| BRCA mutation-positive and HER2-negative breast cancer | indication | 767444009 | |
| BRCA mutation-positive ovarian cancer | indication | 1196879002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.54 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 50MG | LYNPARZA | ASTRAZENECA | N206162 | Dec. 19, 2014 | DISCN | CAPSULE | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8071579 | Aug. 12, 2027 | TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8143241 | Aug. 12, 2027 | TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY |
| 50MG | LYNPARZA | ASTRAZENECA | N206162 | Dec. 19, 2014 | DISCN | CAPSULE | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 8859562 | Aug. 4, 2031 | TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 11970530 | Oct. 25, 2041 | MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF ADVANCED EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 11970530 | Oct. 25, 2041 | MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 11970530 | Oct. 25, 2041 | MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 11970530 | Oct. 25, 2041 | MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF ADVANCED EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 11970530 | Oct. 25, 2041 | MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | 11970530 | Oct. 25, 2041 | MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | May 31, 2026 | IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | May 31, 2026 | IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | Dec. 27, 2026 | MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | Dec. 27, 2026 | MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC |
| 100MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | May 8, 2027 | W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY |
| 150MG | LYNPARZA | ASTRAZENECA | N208558 | Aug. 17, 2017 | RX | TABLET | ORAL | May 8, 2027 | W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Poly [ADP-ribose] polymerase 2 | Enzyme | INHIBITOR | IC50 | 9 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Poly [ADP-ribose] polymerase 1 | Enzyme | INHIBITOR | IC50 | 8.30 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Poly [ADP-ribose] polymerase 3 | Enzyme | INHIBITOR | IC50 | 7.34 | CHEMBL | DRUG LABEL | |||
| Poly [ADP-ribose] polymerase 10 | Enzyme | IC50 | 5.90 | CHEMBL | |||||
| Poly [ADP-ribose] polymerase 12 | Enzyme | IC50 | 5 | CHEMBL | |||||
| Poly [ADP-ribose] polymerase 14 | Enzyme | IC50 | 4.81 | CHEMBL | |||||
| Poly [ADP-ribose] polymerase 15 | Enzyme | IC50 | 4.75 | CHEMBL | |||||
| Cyclin-dependent kinase 6 | Kinase | IC50 | 8.64 | CHEMBL | |||||
| Mono [ADP-ribose] polymerase PARP16 | Enzyme | IC50 | 5.29 | CHEMBL | |||||
| Poly [ADP-ribose] polymerase 8 | Enzyme | IC50 | 6.62 | CHEMBL | |||||
| Tankyrase-1 | Enzyme | IC50 | 5.82 | SCIENTIFIC LITERATURE | |||||
| Poly [ADP-ribose] polymerase 6 | Enzyme | IC50 | 5.75 | CHEMBL | |||||
| Tankyrase-2 | Enzyme | IC50 | 8.28 | CHEMBL | |||||
| Poly [ADP-ribose] polymerase 4 | Enzyme | IC50 | 6.39 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D09730 | KEGG_DRUG |
| 4034034 | VUID |
| N0000191291 | NUI |
| 4034034 | VANDF |
| CHEBI:83766 | CHEBI |
| 09L | PDB_CHEM_ID |
| CHEMBL521686 | ChEMBL_ID |
| C531550 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7519 | IUPHAR_LIGAND_ID |
| DB09074 | DRUGBANK_ID |
| 1597582 | RXNORM |
| 231537 | MMSL |
| 30771 | MMSL |
| d08319 | MMSL |
| 015824 | NDDF |
| 432162002 | SNOMEDCT_US |
| 432885003 | SNOMEDCT_US |
| C2316164 | UMLSCUI |
| 8685 | INN_ID |
| 23725625 | PUBCHEM_CID |
| WOH1JD9AR8 | UNII |
| WOH1JD9AR8 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Lynparza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-0569 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 26 sections |
| Lynparza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-0578 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 26 sections |
| Lynparza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-0668 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 26 sections |
| Lynparza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-0679 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 26 sections |