FDA accepts filing of NDA for Lynparza for patients with metastatic castration-resistant prostate cancer . AstraZeneca + Merck Inc.
AstraZeneca and MSD Inc.,announced that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, who have progressed following prior treatment with a new hormonal agent.
A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020. The Priority Review by the FDA is based on results from the Phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress.
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