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In April 2018 it was granted FDA approval. Niraparib: In March 2017 approved by US FDA for epithelial ovarian, fallopian tube, and primary peritoneal cancer. [9] [10] Inhibitor of PARP1 and PARP2. [11] Talazoparib was approved in 2018 by US FDA for breast cancer with germline BRCA mutations. [12]
The FDA approval was for germline BRCA mutated (gBRCAm) advanced ovarian cancer that has received three or more prior lines of chemotherapy. [7] In January 2018, olaparib became the first PARP inhibitor to be approved by the FDA for gBRCAm metastatic breast cancer.
It was approved on 27 March 2017 in the US, [5] and approved in European Union on 16 November 2017. [ 15 ] In a study with 553 patients, progression-free survival (PFS) for patients with a deleterious or suspected deleterious BRCA mutation in the germline was 21.0 months under niraparib therapy, as compared to 5.5 months under placebo .
FDA approves AstraZeneca (AZN)/Merck's (MRK) PARP inhibitor Lynparza for HRR gene-mutated metastatic castration-resistant prostate cancer. The approval was based on data from the phase III ...
Clovis' (CLVS) PARP inhibitor, Rubraca, receives approval from the FDA as monotherapy to treat BRCA-mutant metastatic castration-resistant prostate cancer.
AstraZeneca Plc’s (AZN) and Merck Co.’s (MRK) Lynparza drug has received a green light from the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced prostate ...
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