Astrazeneca's olaparib drug voted against by FDA advisory committee - UPDATE

26th Jun 2014 07:08

It was disappointing news for AstraZeneca after an advisory committee to the US Food and Drug Administration (FDA) voted 11 to two that there was not enough evidence to support an accelerated approval for the use of olaparib as a maintenance treatment for women with a specific type of ovarian cancer. The Oncologic Drugs Advisory Committee, which provides the FDA with independent expert advice and recommendations, will influence the final decision on approval of olaparib's use in patients with ovarian cancer who have the BRCA mutation and who are in complete or partial response to a platinum-based form of chemotherapy. AstraZeneca filed the US regulatory submission for olaparib in February 2014 and was granted priority review status for the new drug application (NDA) by the FDA in April based on data that showed the drug met its primary endpoint of progression-free survival in a specific type of the disease. Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer said: "We are disappointed with today's recommendation, and strongly believe that olaparib has the potential to provide patients with relapsed BRCA-mutated ovarian cancer and their doctors with a much-needed treatment option."The group also said that it has initiated the third phase of the SOLO programme, which has been designed to evaluate the efficacy and safety of olaparib as a maintenance therapy in certain types of ovarian cancer patients who have a BRCA mutation. "We look forward to continuing to work with the FDA as it evaluates the advisory committee recommendation and completes its review of the application. In the meantime, we are continuing with our phase III clinical programme to evaluate the benefit of olaparib for this patient population. We aim to have completed this study by the end of 2015," Morrison added. Shares in Astra rose 0.44% to 4,381p by 08:45 on Thursday.NR