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The FDA’s Oncologic Drugs Advisory Committee voted 7 to 5 in favor of olaparib 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 has scheduled an Oncologic Drugs Advisory Committee hearing for December 17, 2019, to discuss a supplemental new drug application for olaparib tablets 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.

Innovative clinical trials designed to exploit the explosion of data on the drivers of cancer are demonstrating value as tools to explore potential signals of efficacy across tumor types, according to oncology experts. These studies have become a feature of the drug discovery landscape in oncology and are likely to remain part of the fabric of clinical research in the genomic era.