ODAC Votes Against Maintenance Olaparib in BRCA-Positive Ovarian Cancer

June 25, 2014 7:12 PM

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The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11-2 against the accelerated approval of the PARP inhibitor olaparib as a maintenance therapy for women with platinum-sensitive relapsed ovarian cancer with germline BRCA mutations.

By voting no, the committee recommended waiting for results from the larger phase III SOLO-2 trial, which began enrolling in 2013. The primary endpoint of this study is progression-free survival (PFS) by RECIST criteria. OS will remain a secondary endpoint, as was the case in earlier phase II trials...

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