FDA Advisory Committee rejects olaparib for Ovarian Cancer-AstraZeneca

AstraZeneca announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 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 NDA filing was based on a subgroup analysis of Phase II data recently published in Lancet Oncology. The Phase II study was a randomised, double-blind, placebo-controlled trial which evaluated olaparib versus placebo as maintenance treatment in platinum-sensitive relapsed serous ovarian cancer patients who had received previous treatment with at least two platinum regimens and were in a maintained partial or complete response following their last platinum regimen. The study met its primary endpoint of progression-free survival by Response Evaluation Criteria in Solid Tumours guidelines. A pre-defined subgroup analysis was conducted in patients who have germline BRCA mutations.

AstraZeneca has initiated the Phase III SOLO programme, designed to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in ovarian cancer patients who have a BRCA mutation who are in complete or partial response following platinum-based chemotherapy in the relapsed setting.