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
S (Water solubility)	0.10 mg/mL	Bocci G, Oprea TI, 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	1933.07	28.19	655	9599	81466	63397302
Anaemia	1090.88	28.19	640	9614	292790	63185978
Myelodysplastic syndrome	1016.18	28.19	278	9976	16476	63462292
Acute myeloid leukaemia	747.59	28.19	220	10034	16927	63461841
Death	581.53	28.19	479	9775	373902	63104866
Myelosuppression	446.02	28.19	161	10093	23542	63455226
Interstitial lung disease	410.95	28.19	200	10054	61708	63417060
Ovarian cancer recurrent	384.73	28.19	75	10179	942	63477826
Carbohydrate antigen 125 increased	263.18	28.19	66	10188	2750	63476018
Pancytopenia	192.00	28.19	144	10110	96789	63381979
Neutrophil count decreased	181.17	28.19	113	10141	56293	63422475
Haematotoxicity	169.85	28.19	62	10192	9314	63469454
Tumour marker increased	158.06	28.19	50	10204	4865	63473903
Platelet count decreased	152.87	28.19	136	10118	115986	63362782
Nausea	148.94	28.19	383	9871	854088	62624680
Disease progression	144.44	28.19	135	10119	122623	63356145
Metastases to liver	117.61	28.19	63	10191	23576	63455192
Renal impairment	111.29	28.19	101	10153	88254	63390514
Thrombocytopenia	110.70	28.19	129	10125	151028	63327740
Metastases to peritoneum	110.60	28.19	35	10219	3407	63475361
Metastases to central nervous system	88.69	28.19	43	10211	13062	63465706
Pneumonitis	80.18	28.19	57	10197	35165	63443603
Ileus	78.19	28.19	41	10213	14684	63464084
Metastases to lymph nodes	77.89	28.19	34	10220	8124	63470644
Acute erythroid leukaemia	77.57	28.19	13	10241	63	63478705
Bone marrow failure	70.38	28.19	49	10205	29241	63449527
Second primary malignancy	65.85	28.19	30	10224	7923	63470845
Metastasis	64.13	28.19	26	10228	5171	63473597
Metastases to bone	54.83	28.19	37	10217	20982	63457786
Blood creatinine increased	49.78	28.19	66	10188	87778	63390990
Acute leukaemia	46.90	28.19	14	10240	1120	63477648
Acute megakaryocytic leukaemia	46.58	28.19	8	10246	46	63478722
Metastases to pleura	46.33	28.19	15	10239	1570	63477198
Pain	45.80	28.19	32	10222	740596	62738172
Acquired gene mutation	44.44	28.19	13	10241	970	63477798
BRCA2 gene mutation	41.82	28.19	8	10246	90	63478678
TP53 gene mutation	40.51	28.19	7	10247	42	63478726
White blood cell count decreased	40.46	28.19	77	10177	139027	63339741
Neutropenia	40.38	28.19	88	10166	174917	63303851
Intestinal obstruction	40.17	28.19	36	10218	30863	63447905
Metastases to lung	39.50	28.19	25	10229	12725	63466043
Transformation to acute myeloid leukaemia	39.25	28.19	9	10245	254	63478514
Leukaemia	38.42	28.19	17	10237	4191	63474577
Taste disorder	35.51	28.19	24	10230	13638	63465130
Recurrent cancer	35.45	28.19	13	10241	1974	63476794
Haemoglobin decreased	34.51	28.19	74	10180	145411	63333357
Refractory anaemia with an excess of blasts	34.51	28.19	9	10245	438	63478330
Drug resistance	34.42	28.19	29	10225	22904	63455864
Musculoskeletal toxicity	31.75	28.19	6	10248	63	63478705
Drug ineffective	31.74	28.19	77	10177	1044688	62434080
Disease recurrence	31.29	28.19	30	10224	28000	63450768
Neoplasm progression	29.82	28.19	33	10221	36395	63442373
Metastases to meninges	28.65	28.19	12	10242	2590	63476178
Ascites	28.47	28.19	34	10220	40694	63438074
Ovarian cancer metastatic	28.31	28.19	9	10245	888	63477880

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	439.13	43.04	270	1711	397779	34557171
Malignant neoplasm progression	346.76	43.04	143	1838	87903	34867047
Anaemia	103.27	43.04	93	1888	233242	34721708
Prostatic specific antigen increased	93.27	43.04	34	1947	14646	34940304
Product use issue	83.28	43.04	49	1932	63167	34891783
Off label use	73.41	43.04	103	1878	419421	34535529
Fatigue	69.24	43.04	94	1887	370559	34584391
Product use in unapproved indication	59.99	43.04	51	1930	117448	34837502
Metastases to bone	51.87	43.04	21	1960	11949	34943001

FDA Adverse Event Reporting System (Geriatric)

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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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 pancreas	indication	363418001
Malignant tumor of ovary	indication	363443007	DOID:2394
Malignant tumor of peritoneum	indication	363492001
Hormone refractory prostate cancer	indication	427492003
Human epidermal growth factor 2 negative carcinoma of breast	indication	431396003
BRCA mutation-positive and HER2-negative breast cancer	indication	767444009

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation 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 HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9169235	March 12, 2024	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9169235	March 12, 2024	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9169235	March 12, 2024	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9566276	March 12, 2024	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8912187	March 12, 2024	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9169235	March 12, 2024	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9169235	March 12, 2024	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9169235	March 12, 2024	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	9566276	March 12, 2024	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
50MG	LYNPARZA	ASTRAZENECA	N206162	Dec. 19, 2014	DISCN	CAPSULE	ORAL	8143241	Aug. 12, 2027	TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8071579	Aug. 12, 2027	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8143241	Aug. 12, 2027	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
50MG	LYNPARZA	ASTRAZENECA	N206162	Dec. 19, 2014	DISCN	CAPSULE	ORAL	8859562	Aug. 4, 2031	TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	ADJUVANT TREATMENT OF PATIENTS WITH GBRCA-MUTATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE HIGH RISK EARLY BREAST CANCER WHO HAVE BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	8859562	Aug. 4, 2031	TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 8, 2023	W/BEVACIZUMAB FOR MAINTENANCE TX OF ADULTS W/ADV. EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMO & CA ASSOCIATED W/ HOMOLOGOUS RECOMBINATION DEFICIENCY POSITIVE STATUS
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 8, 2023	W/BEVACIZUMAB FOR MAINTENANCE TX OF ADULTS W/ADV. EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMO & CA ASSOCIATED W/ HOMOLOGOUS RECOMBINATION DEFICIENCY POSITIVE STATUS
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 19, 2023	TX OF ADULT PTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 19, 2023	TX OF ADULT PTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Aug. 17, 2024	MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Aug. 17, 2024	TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Aug. 17, 2024	MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Aug. 17, 2024	TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	March 11, 2025	FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	March 11, 2025	FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Dec. 19, 2025	MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Dec. 19, 2025	MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 31, 2026	IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THETREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC)
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 31, 2026	IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THETREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC)
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Dec. 27, 2026	MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	Dec. 27, 2026	MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
100MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 8, 2027	W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY
150MG	LYNPARZA	ASTRAZENECA	N208558	Aug. 17, 2017	RX	TABLET	ORAL	May 8, 2027	W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY

Bioactivity Summary:

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
DB09074	DRUGBANK_ID
1597582	RXNORM
231537	MMSL
30771	MMSL
d08319	MMSL
015824	NDDF
432162002	SNOMEDCT_US
432885003	SNOMEDCT_US
C2316164	UMLSCUI
8685	INN_ID
23725625	PUBCHEM_CID
WOH1JD9AR8	UNII

Pharmaceutical products:

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