The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 in favor of olaparib (Lynparza) tablets for an indication as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.
The FDA scheduled an Oncologic Drugs Advisory Committee hearing to discuss a supplemental new drug application (sNDA) for olaparib in this setting, which was based on results from the phase III POLO trial. Read more . . .