FDA requests additional information on AstraZeneca's ovarian cancer drug
- The FDA Oncologic Drugs Advisory Committee voted 11-2 in favor of requiring AstraZeneca to submit additional information on olaparib. This request was made in response to the company’s request for accelerated approval.
- FDA requested additional efficacy information and also noted safety concerns related to a potential drug-related increased risk of secondary cancers.
- The drug won’t be approved before 2016.
AstraZeneca had been attempting to pursue accelerated approval based on phase II data, but FDA advisors responded that more efficacy data would be required, citing concerns about the reproducibility of the efficacy data that AstraZeneca filed. Despite this, phase III trials are underway and will be completed by the end of next year.
While some commentators have raised concerns that this development may weaken AstraZeneca’s stance with regard to Pfizer’s offer (which AstraZeneca considers too low), long-term prospects for olaparib are yet to be determined.
- www.seekingalpha.com No accelerated approval for olaparib