Home » Lynparza Approved for Metastatic Pancreatic Cancer
Lynparza Approved for Metastatic Pancreatic Cancer
January 7, 2020
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.
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