olaparib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
poly-ADP-ribose polymerase inhibitors 4907 763113-22-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • olaparib
  • lynparza
  • AZD2281
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.
  • Molecular weight: 434.47
  • Formula: C24H23FN4O3
  • CLOGP: 1.07
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 82.08
  • ALOGS: -3.86
  • ROTB: 4
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.60 g O

ADMET properties:

PropertyValueReference
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):

PropertyDescriptionValueUnitConfidenceSimilarity
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:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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
abiraterone acetateniraparibrucaparibtalazoparib tosylate

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 11.54 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA 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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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