Negative view from FDA advisory for AstraZeneca's olaparib

There was disappointment for Anglo-Swedish pharma major AstraZeneca (LSE: AZN) yesterday when a US Food and Drug Administration advisory panel voted against approval of its investigational ovarian cancer drug.

The FDA Oncologic Drugs Advisory Committee (ODAC) voted 11 to two that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have the germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy. The panel called for more clinical data.

AstraZeneca filed the US regulatory submission for olaparib in February 2014. The FDA granted priority review status for the NDA in April and set a Prescription Drug User Fee Act (PDUFA) action date of 3 October 2014. The drug candidate was  granted priority review status in April. The ODAC provides the FDA with independent, expert advice and recommendations, however the final decision regarding approval is made by the FDA.