olaparib 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: 1.24
  • 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

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 1627.88 27.93 534 6803 71007 53270722
Anaemia 747.11 27.93 464 6873 276254 53065475
Myelodysplastic syndrome 671.94 27.93 194 7143 16466 53325263
Acute myeloid leukaemia 589.64 27.93 176 7161 16756 53324973
Ovarian cancer recurrent 243.34 27.93 51 7286 1112 53340617
Death 242.58 27.93 270 7067 356962 52984767
Carbohydrate antigen 125 increased 228.27 27.93 56 7281 2512 53339217
Myelosuppression 197.15 27.93 72 7265 12756 53328973
Interstitial lung disease 181.00 27.93 108 7229 58514 53283215
Nausea 125.62 27.93 301 7036 755790 52585939
Disease progression 123.05 27.93 106 7231 101814 53239915
Neutrophil count decreased 110.23 27.93 74 7263 49024 53292705
Metastases to peritoneum 98.72 27.93 30 7307 3005 53338724
Pancytopenia 98.57 27.93 89 7248 90839 53250890
Haematotoxicity 98.27 27.93 38 7299 7859 53333870
Metastases to liver 94.51 27.93 50 7287 21446 53320283
Tumour marker increased 90.92 27.93 30 7307 3923 53337806
Platelet count decreased 83.72 27.93 88 7249 108011 53233718
Metastases to central nervous system 82.76 27.93 38 7299 12019 53329710
Pneumonitis 75.21 27.93 49 7288 30839 53310890
Bone marrow failure 71.43 27.93 47 7290 30068 53311661
Thrombocytopenia 67.48 27.93 89 7248 138638 53203091
Renal impairment 66.57 27.93 69 7268 83249 53258480
Ileus 66.33 27.93 35 7302 14920 53326809
Metastases to lymph nodes 65.73 27.93 28 7309 7412 53334317
Metastasis 52.64 27.93 21 7316 4710 53337019
BRCA2 gene mutation 52.45 27.93 9 7328 62 53341667
Metastases to pleura 51.20 27.93 15 7322 1324 53340405
Intestinal obstruction 41.04 27.93 33 7304 28708 53313021
Metastases to bone 40.63 27.93 28 7309 19300 53322429
Acquired gene mutation 40.09 27.93 11 7326 766 53340963
Acute leukaemia 39.85 27.93 12 7325 1164 53340565
Taste disorder 39.21 27.93 20 7317 7948 53333781
Blood creatinine increased 38.54 27.93 52 7285 82610 53259119
Musculoskeletal toxicity 36.13 27.93 6 7331 33 53341696
Ovarian cancer 34.74 27.93 17 7320 6185 53335544
Disease recurrence 34.12 27.93 26 7311 20920 53320809
Metastases to lung 32.03 27.93 20 7317 11684 53330045
Drug ineffective 31.43 27.93 40 7297 817205 52524524
Haemoglobin decreased 29.53 27.93 61 7276 137246 53204483
Erythroblastosis 28.80 27.93 4 7333 4 53341725
Porokeratosis 28.47 27.93 6 7331 134 53341595

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
Malignant neoplasm progression 194.56 48.85 75 840 78421 32434190
Death 186.99 48.85 120 795 382397 32130214
Off label use 100.61 48.85 76 839 306244 32206367
Product use in unapproved indication 86.42 48.85 44 871 87160 32425451
Prostatic specific antigen increased 52.41 48.85 18 897 13169 32499442

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 cytostatic
CHEBI has role CHEBI:62913 poly(ADP-ribose) polymerase inhibitors
CHEBI has role CHEBI:68495 Type I programmed cell-death inducer

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Epithelial tumor of ovary indication 237057005 DOID:2152
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

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Dec. 27, 2022 MAINTENANCE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM 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 Dec. 27, 2022 MAINTENANCE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM 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 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 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 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
8685 INN_ID
DB09074 DRUGBANK_ID
WOH1JD9AR8 UNII
23725625 PUBCHEM_CID
1597582 RXNORM
231537 MMSL
30771 MMSL
d08319 MMSL
015824 NDDF
432162002 SNOMEDCT_US
432885003 SNOMEDCT_US
C2316164 UMLSCUI

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 0310-0679 TABLET, FILM COATED 150 mg ORAL NDA 26 sections