The U.S. Food and Drug Administration (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 mutation, and who are in complete or partial response to platinum-based chemotherapy.
The ODAC provides the FDA with independent, expert advice and recommendations, however, the final decision regarding approval is made by the FDA. The FDA granted priority review status for the New Drug Application (NDA) in April and set a Prescription Drug User Fee Act (PDUFA) action date of October 3, 2014.
The NDA filing was based on a subgroup analysis of phase II data recently published in The Lancet Oncology.1 The phase II study was a randomized, double-blind, placebo-controlled trial that evaluated olaparib vs 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. A predefined subgroup analysis was conducted in patients who have germline BRCA mutations.
Phase III Study Underway
A phase III trial (SOLO) has been initiated to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in patients with BRCA-mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the relapsed setting.
There are few treatment options available for patients with germline BRCA-mutated serous ovarian cancer, said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, in a statement. “[W]e are continuing with our phase III clinical program to evaluate the benefit of olaparib for this patient population. We aim to have completed this study by the end of 2015.” ■
1. Ledermann J, Harter P, Gourley C,, et al: Olaparib maintenance therapy in patients with platinum-sensitive relapsed srous ovarian cancer: A preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial. Lancet Oncol. May 30, 2014 (early release online).