LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy
Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results
KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7-5 to recommend LYNPARZA as a first-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy.
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