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

Stem definition	Drug id	CAS RN
poly-ADP-ribose polymerase inhibitors	4907	763113-22-0

Description:

Molecule	Description
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

Molecule

Description

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:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ

Approvals:

Date	Agency	Company
Jan. 19, 2018	PMDA	AstraZeneca KK
Dec. 19, 2014	FDA	ASTRAZENECA PHARMS
Oct. 23, 2014	EMA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	1663.44	28.70	552	7268	67572	50529732
Anaemia	823.10	28.70	498	7322	251958	50345346
Myelodysplastic syndrome	753.23	28.70	213	7607	14919	50582385
Acute myeloid leukaemia	633.21	28.70	186	7634	14888	50582416
Death	277.54	28.70	293	7527	325086	50272218
Carbohydrate antigen 125 increased	234.03	28.70	58	7762	2409	50594895
Ovarian cancer recurrent	227.90	28.70	47	7773	835	50596469
Myelosuppression	217.78	28.70	81	7739	13436	50583868
Interstitial lung disease	208.08	28.70	119	7701	53057	50544247
Nausea	139.86	28.70	323	7497	705075	49892229
Neutrophil count decreased	130.89	28.70	84	7736	45942	50551362
Disease progression	123.92	28.70	109	7711	95757	50501547
Metastases to liver	112.13	28.70	57	7763	20047	50577257
Haematotoxicity	107.96	28.70	42	7778	7853	50589451
Pancytopenia	107.47	28.70	95	7725	83935	50513369
Metastases to peritoneum	101.56	28.70	31	7789	2802	50594502
Platelet count decreased	98.32	28.70	98	7722	100628	50496676
Tumour marker increased	92.29	28.70	31	7789	3809	50593495
Metastases to central nervous system	84.03	28.70	39	7781	11243	50586061
Thrombocytopenia	82.45	28.70	100	7720	127573	50469731
Pneumonitis	76.84	28.70	51	7769	29459	50567845
Renal impairment	72.64	28.70	73	7747	75588	50521716
Ileus	72.27	28.70	37	7783	13192	50584112
Bone marrow failure	67.74	28.70	46	7774	27578	50569726
Metastases to lymph nodes	67.41	28.70	29	7791	6995	50590309
Metastasis	55.32	28.70	22	7798	4353	50592951
Metastases to pleura	49.84	28.70	15	7805	1291	50596013
Acute leukaemia	48.19	28.70	14	7806	1066	50596238
BRCA2 gene mutation	44.98	28.70	8	7812	61	50597243
Metastases to bone	44.18	28.70	30	7790	17965	50579339
Intestinal obstruction	42.25	28.70	34	7786	26349	50570955
Acquired gene mutation	38.09	28.70	11	7809	820	50596484
Drug ineffective	37.63	28.70	43	7777	819290	49778014
Blood creatinine increased	37.13	28.70	52	7768	76108	50521196
Taste disorder	36.19	28.70	20	7800	8304	50589000
Musculoskeletal toxicity	34.06	28.70	6	7814	43	50597261
Haemoglobin decreased	33.73	28.70	66	7754	127150	50470154
Acute erythroid leukaemia	33.70	28.70	6	7814	46	50597258
Metastases to lung	33.48	28.70	21	7799	10999	50586305
Disease recurrence	32.41	28.70	26	7794	20055	50577249
Second primary malignancy	31.12	28.70	17	7803	6897	50590407
Pain	30.37	28.70	27	7793	578876	50018428
Neutropenia	30.21	28.70	69	7751	147896	50449408

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	232.68	45.12	91	1024	73768	29499644
Death	192.15	45.12	131	984	341953	29231459
Off label use	85.81	45.12	78	1037	300722	29272690
Product use in unapproved indication	85.06	45.12	48	1067	86827	29486585
Prostatic specific antigen increased	55.51	45.12	20	1095	12544	29560868

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	906.40	30.50	363	6296	112508	64379565
Anaemia	684.08	30.50	443	6216	378237	64113836
Acute myeloid leukaemia	530.87	30.50	170	6489	27293	64464780
Myelodysplastic syndrome	497.44	30.50	162	6497	27417	64464656
Myelosuppression	184.15	30.50	75	6584	23755	64468318
Ovarian cancer recurrent	165.13	30.50	29	6630	320	64491753
Nausea	160.00	30.50	287	6372	785513	63706560
Death	146.79	30.50	212	6447	482493	64009580
Interstitial lung disease	140.06	30.50	100	6559	97632	64394441
Neutrophil count decreased	117.53	30.50	82	6577	77114	64414959
Carbohydrate antigen 125 increased	115.73	30.50	29	6630	1899	64490174
Metastases to liver	103.00	30.50	50	6609	23891	64468182
Metastases to lymph nodes	94.11	30.50	35	6624	8682	64483391
Metastases to peritoneum	89.53	30.50	27	6632	3520	64488553
Platelet count decreased	81.08	30.50	93	6566	167618	64324455
Disease progression	67.49	30.50	78	6581	141602	64350471
Pneumonitis	64.02	30.50	48	6611	50317	64441756
Thrombocytopenia	62.81	30.50	95	6564	223706	64268367
Pancytopenia	61.81	30.50	75	6584	143234	64348839
Metastases to bone	59.93	30.50	33	6626	20402	64471671
Bone marrow failure	57.19	30.50	44	6615	47908	64444165
Metastases to pleura	56.31	30.50	15	6644	1249	64490824
Metastases to central nervous system	53.70	30.50	27	6632	13885	64478188
Metastasis	44.20	30.50	18	6641	5677	64486396
Acute leukaemia	43.95	30.50	13	6646	1585	64490488
BRCA2 gene mutation	40.48	30.50	7	6652	70	64492003
Renal impairment	40.22	30.50	59	6600	134958	64357115
Haematotoxicity	38.28	30.50	21	6638	12875	64479198
Acute erythroid leukaemia	37.95	30.50	8	6651	241	64491832
Neutropenia	37.69	30.50	79	6580	239545	64252528
Acquired gene mutation	37.05	30.50	12	6647	1974	64490099
Ileus	36.30	30.50	25	6634	22941	64469132
Intestinal obstruction	34.14	30.50	29	6630	36257	64455816
Tumour marker increased	34.13	30.50	13	6646	3437	64488636
Second primary malignancy	33.65	30.50	19	6640	12318	64479755
White blood cell count decreased	32.06	30.50	58	6601	157779	64334294
Fatigue	32.03	30.50	157	6502	748573	63743500
Drug resistance	30.89	30.50	27	6632	35075	64456998

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XK01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Poly (ADP-ribose) polymerase (PARP) inhibitors
MeSH PA	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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.54	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
50MG	LYNPARZA	ASTRAZENECA	N206162	Dec. 19, 2014	DISCN	CAPSULE	ORAL	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 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	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 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	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 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	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 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	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 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	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 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	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 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	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 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	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	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	Dec. 27, 2026	MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Dec. 27, 2026	MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 8, 2027	W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 8, 2027	W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Poly [ADP-ribose] polymerase 2	Enzyme	Q9UGN5	PARP2_HUMAN	INHIBITOR	IC50	9	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Poly [ADP-ribose] polymerase 1	Enzyme	P09874	PARP1_HUMAN	INHIBITOR	IC50	8.30	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Poly [ADP-ribose] polymerase 3	Enzyme	Q9Y6F1	PARP3_HUMAN	INHIBITOR	IC50	7.34	CHEMBL	DRUG LABEL
Poly [ADP-ribose] polymerase 12	Enzyme	Q9H0J9	PAR12_HUMAN		IC50	5	CHEMBL
Poly [ADP-ribose] polymerase 15	Enzyme	Q460N3	PAR15_HUMAN		IC50	4.75	CHEMBL
Tankyrase-2	Enzyme	Q9H2K2	TNKS2_HUMAN		IC50	8.28	CHEMBL
Mono [ADP-ribose] polymerase PARP16	Unclassified	Q8N5Y8	PAR16_HUMAN		IC50	5.29	CHEMBL
Tankyrase-1	Enzyme	O95271	TNKS1_HUMAN		IC50	5.82	SCIENTIFIC LITERATURE
Poly [ADP-ribose] polymerase 6	Unclassified	Q2NL67	PARP6_HUMAN		IC50	5.75	CHEMBL
Poly [ADP-ribose] polymerase 4	Enzyme	Q9UKK3	PARP4_HUMAN		IC50	6.39	CHEMBL
Poly [ADP-ribose] polymerase 10	Enzyme	Q53GL7	PAR10_HUMAN		IC50	5.90	CHEMBL

External reference:

ID	Source
D09730	KEGG_DRUG
4034034	VUID
N0000191291	NUI
4034034	VANDF
CHEBI:83766	CHEBI
09L	PDB_CHEM_ID
CHEMBL521686	ChEMBL_ID
C531550	MESH_SUPPLEMENTAL_RECORD_UI
7519	IUPHAR_LIGAND_ID
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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