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FDA Accepts Regulatory Submission Of Supplemental New Drug Application For Merck's LYNPARZA In HRR-Mutated Metastatic Castration-Resistant Prostate Cancer And Grants Priority Review

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S.

Benzinga · 01/21/2020 11:56

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of 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.