Lynparza Approved for Metastatic Pancreatic Cancer

The FDA approved AstraZeneca and Merck’s Lynparza (olaparib) for the maintenance treatment of adult patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer whose disease has not progressed after at least 16 weeks of a first-line platinum-based chemotherapy regimen.

The approval was based on the results of a phase 3 clinical trial in which Lynparza doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months compared with 3.8 months when given the placebo.

The approval follows the recommendation of the agency’s Oncologic Drugs Advisory Committee, which voted 7-5 in favor of the indication despite some concerns about the quality of life data.