olaparib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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:

None

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

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 1933.07 28.19 655 9599 81466 63397302
Anaemia 1090.88 28.19 640 9614 292790 63185978
Myelodysplastic syndrome 1016.18 28.19 278 9976 16476 63462292
Acute myeloid leukaemia 747.59 28.19 220 10034 16927 63461841
Death 581.53 28.19 479 9775 373902 63104866
Myelosuppression 446.02 28.19 161 10093 23542 63455226
Interstitial lung disease 410.95 28.19 200 10054 61708 63417060
Ovarian cancer recurrent 384.73 28.19 75 10179 942 63477826
Carbohydrate antigen 125 increased 263.18 28.19 66 10188 2750 63476018
Pancytopenia 192.00 28.19 144 10110 96789 63381979
Neutrophil count decreased 181.17 28.19 113 10141 56293 63422475
Haematotoxicity 169.85 28.19 62 10192 9314 63469454
Tumour marker increased 158.06 28.19 50 10204 4865 63473903
Platelet count decreased 152.87 28.19 136 10118 115986 63362782
Nausea 148.94 28.19 383 9871 854088 62624680
Disease progression 144.44 28.19 135 10119 122623 63356145
Metastases to liver 117.61 28.19 63 10191 23576 63455192
Renal impairment 111.29 28.19 101 10153 88254 63390514
Thrombocytopenia 110.70 28.19 129 10125 151028 63327740
Metastases to peritoneum 110.60 28.19 35 10219 3407 63475361
Metastases to central nervous system 88.69 28.19 43 10211 13062 63465706
Pneumonitis 80.18 28.19 57 10197 35165 63443603
Ileus 78.19 28.19 41 10213 14684 63464084
Metastases to lymph nodes 77.89 28.19 34 10220 8124 63470644
Acute erythroid leukaemia 77.57 28.19 13 10241 63 63478705
Bone marrow failure 70.38 28.19 49 10205 29241 63449527
Second primary malignancy 65.85 28.19 30 10224 7923 63470845
Metastasis 64.13 28.19 26 10228 5171 63473597
Metastases to bone 54.83 28.19 37 10217 20982 63457786
Blood creatinine increased 49.78 28.19 66 10188 87778 63390990
Acute leukaemia 46.90 28.19 14 10240 1120 63477648
Acute megakaryocytic leukaemia 46.58 28.19 8 10246 46 63478722
Metastases to pleura 46.33 28.19 15 10239 1570 63477198
Pain 45.80 28.19 32 10222 740596 62738172
Acquired gene mutation 44.44 28.19 13 10241 970 63477798
BRCA2 gene mutation 41.82 28.19 8 10246 90 63478678
TP53 gene mutation 40.51 28.19 7 10247 42 63478726
White blood cell count decreased 40.46 28.19 77 10177 139027 63339741
Neutropenia 40.38 28.19 88 10166 174917 63303851
Intestinal obstruction 40.17 28.19 36 10218 30863 63447905
Metastases to lung 39.50 28.19 25 10229 12725 63466043
Transformation to acute myeloid leukaemia 39.25 28.19 9 10245 254 63478514
Leukaemia 38.42 28.19 17 10237 4191 63474577
Taste disorder 35.51 28.19 24 10230 13638 63465130
Recurrent cancer 35.45 28.19 13 10241 1974 63476794
Haemoglobin decreased 34.51 28.19 74 10180 145411 63333357
Refractory anaemia with an excess of blasts 34.51 28.19 9 10245 438 63478330
Drug resistance 34.42 28.19 29 10225 22904 63455864
Musculoskeletal toxicity 31.75 28.19 6 10248 63 63478705
Drug ineffective 31.74 28.19 77 10177 1044688 62434080
Disease recurrence 31.29 28.19 30 10224 28000 63450768
Neoplasm progression 29.82 28.19 33 10221 36395 63442373
Metastases to meninges 28.65 28.19 12 10242 2590 63476178
Ascites 28.47 28.19 34 10220 40694 63438074
Ovarian cancer metastatic 28.31 28.19 9 10245 888 63477880

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 439.13 43.04 270 1711 397779 34557171
Malignant neoplasm progression 346.76 43.04 143 1838 87903 34867047
Anaemia 103.27 43.04 93 1888 233242 34721708
Prostatic specific antigen increased 93.27 43.04 34 1947 14646 34940304
Product use issue 83.28 43.04 49 1932 63167 34891783
Off label use 73.41 43.04 103 1878 419421 34535529
Fatigue 69.24 43.04 94 1887 370559 34584391
Product use in unapproved indication 59.99 43.04 51 1930 117448 34837502
Metastases to bone 51.87 43.04 21 1960 11949 34943001

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 1122.87 29.19 459 8627 135531 79599771
Anaemia 940.18 29.19 596 8490 444419 79290883
Myelodysplastic syndrome 708.42 29.19 222 8864 30079 79705223
Acute myeloid leukaemia 617.75 29.19 201 8885 30684 79704618
Death 406.08 29.19 403 8683 566111 79169191
Myelosuppression 313.46 29.19 131 8955 40165 79695137
Ovarian cancer recurrent 267.55 29.19 46 9040 398 79734904
Interstitial lung disease 247.67 29.19 156 8930 112444 79622858
Nausea 188.66 29.19 365 8721 956831 78778471
Neutrophil count decreased 157.52 29.19 110 8976 93849 79641453
Carbohydrate antigen 125 increased 128.59 29.19 33 9053 2151 79733151
Platelet count decreased 128.09 29.19 133 8953 194531 79540771
Pancytopenia 126.97 29.19 123 8963 165622 79569680
Metastases to lymph nodes 105.58 29.19 41 9045 10356 79724946
Metastases to liver 104.36 29.19 55 9031 28259 79707043
Metastases to peritoneum 97.61 29.19 31 9055 4341 79730961
Thrombocytopenia 80.34 29.19 123 8963 265136 79470166
Acute erythroid leukaemia 77.29 29.19 15 9071 266 79735036
Disease progression 74.27 29.19 98 8988 184264 79551038
Haematotoxicity 71.32 29.19 35 9051 15484 79719818
Second primary malignancy 64.86 29.19 32 9054 14318 79720984
Metastases to bone 64.18 29.19 38 9048 24389 79710913
Pneumonitis 63.89 29.19 54 9032 60806 79674496
Renal impairment 62.18 29.19 83 9003 157700 79577602
Metastases to central nervous system 60.86 29.19 32 9054 16343 79718959
Bone marrow failure 54.99 29.19 46 9040 51061 79684241
Metastases to pleura 51.78 29.19 15 9071 1539 79733763
Drug resistance 51.74 29.19 41 9045 42172 79693130
Acute megakaryocytic leukaemia 48.80 29.19 8 9078 50 79735252
Acquired gene mutation 46.42 29.19 15 9071 2218 79733084
Fatigue 45.96 29.19 218 8868 929509 78805793
Metastasis 45.59 29.19 20 9066 6860 79728442
Tumour marker increased 43.91 29.19 17 9069 4255 79731047
TP53 gene mutation 43.09 29.19 7 9079 41 79735261
Ileus 42.24 29.19 30 9056 26181 79709121
Acute leukaemia 41.69 29.19 13 9073 1713 79733589
Neutropenia 41.24 29.19 97 8989 287613 79447689
White blood cell count decreased 40.48 29.19 75 9011 188213 79547089
Metastases to lung 39.39 29.19 25 9061 18138 79717164
BRCA2 gene mutation 37.82 29.19 7 9079 95 79735207
Taste disorder 37.39 29.19 23 9063 15800 79719502
Transformation to acute myeloid leukaemia 34.90 29.19 10 9076 987 79734315
Vomiting 32.68 29.19 156 8930 665672 79069630
Refractory anaemia with an excess of blasts 31.32 29.19 9 9077 897 79734405
Intestinal obstruction 31.12 29.19 31 9055 42989 79692313
Pain 29.92 29.19 22 9064 703780 79031522

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 D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D000067856 Poly(ADP-ribose) Polymerase Inhibitors
FDA MoA N0000191622 Poly(ADP-Ribose) Polymerase Inhibitors
FDA EPC N0000191623 Poly(ADP-Ribose) Polymerase Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:62913 PARP
CHEBI has role CHEBI:68495 Type I cell-death inducers

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 mutation-positive and HER2-negative breast cancer indication 767444009




🐶 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 8912187 March 12, 2024 TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
100MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 9169235 March 12, 2024 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 9169235 March 12, 2024 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 9169235 March 12, 2024 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 9566276 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 8912187 March 12, 2024 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 9169235 March 12, 2024 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 9169235 March 12, 2024 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 9169235 March 12, 2024 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 9566276 March 12, 2024 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

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 8, 2023 W/BEVACIZUMAB FOR MAINTENANCE TX OF ADULTS W/ADV. EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMO & CA ASSOCIATED W/ HOMOLOGOUS RECOMBINATION DEFICIENCY POSITIVE STATUS
150MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL May 8, 2023 W/BEVACIZUMAB FOR MAINTENANCE TX OF ADULTS W/ADV. EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMO & CA ASSOCIATED W/ HOMOLOGOUS RECOMBINATION DEFICIENCY POSITIVE STATUS
100MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL May 19, 2023 TX OF ADULT PTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL May 19, 2023 TX OF ADULT PTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL Aug. 17, 2024 MAINTENANCE TREATMENT OF ADULT PATIENTS WITH 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 Aug. 17, 2024 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
150MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL Aug. 17, 2024 MAINTENANCE TREATMENT OF ADULT PATIENTS WITH 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 Aug. 17, 2024 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
100MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL March 11, 2025 FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
150MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL March 11, 2025 FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
100MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL Dec. 19, 2025 MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
150MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL Dec. 19, 2025 MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
100MG LYNPARZA ASTRAZENECA N208558 Aug. 17, 2017 RX TABLET ORAL May 31, 2026 IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THETREATMENT 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 THETREATMENT 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 12 Enzyme IC50 5 CHEMBL
Poly [ADP-ribose] polymerase 15 Enzyme IC50 4.75 CHEMBL
Tankyrase-2 Enzyme IC50 8.28 CHEMBL
Mono [ADP-ribose] polymerase PARP16 Unclassified IC50 5.29 CHEMBL
Tankyrase-1 Enzyme IC50 5.82 SCIENTIFIC LITERATURE
Poly [ADP-ribose] polymerase 6 Unclassified IC50 5.75 CHEMBL
Poly [ADP-ribose] polymerase 4 Enzyme IC50 6.39 CHEMBL
Poly [ADP-ribose] polymerase 10 Enzyme IC50 5.90 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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lynparza HUMAN PRESCRIPTION DRUG LABEL 1 0310-0668 TABLET, FILM COATED 100 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 0310-0668 TABLET, FILM COATED 100 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
Lynparza HUMAN PRESCRIPTION DRUG LABEL 1 0310-0679 TABLET, FILM COATED 150 mg ORAL NDA 26 sections
Lynparza HUMAN PRESCRIPTION DRUG LABEL 1 0310-0679 TABLET, FILM COATED 150 mg ORAL NDA 26 sections
Lynparza HUMAN PRESCRIPTION DRUG LABEL 1 0310-0679 TABLET, FILM COATED 150 mg ORAL NDA 26 sections