AstraZeneca, the U.K.-based drugmaker that has rejected a $117 billion takeover offer from Pfizer, has disclosed that an ovarian cancer treatment has failed to win support from a U.S. Food and Drug Administration advisory panel.
The FDA’s advisory committee voted 11-2 to support the position that current evidence from clinical studies doesn’t support accelerated approval for use of the drug, olaparib, as a maintenance treatment for some women with ovarian cancer.
AstraZeneca Chief Medical Officer Briggs Morrison said the company was “disappointed” with the recommendation, saying the drugmaker believed the treatment had the potential to provide some ovarian cancer patients a much-needed treatment option.
The FDA’s panel vote is a recommendation and final decisions regarding approval are made by the FDA.
The news is a setback for AstraZeneca’s business. Olaparib is one of a horde of new cancer treatments the company was hoping would become the backbone of its business and reduce its reliance on drugs for diabetes and other ailments.
AstraZeneca in 2011 seemed poised to walk away from olaparib, at the time saying it wouldn’t progress with Phase III development. But last year the company reversed that decision and resurrected the program, and at the time reversed a $285 million impairment charge it had booked in late 2011.
Ovarian caner is the fifth leading cause of cancer mortality for women, according to the FDA, with an estimated 22,000 new cases diagnosed and 14,270 deaths from the disease in the U.S. in 2014. AstraZeneca is attempting to develop a treatment for platinum-sensitive relapsed ovarian cancer who have the germline BRCA mutation. Currently, there aren’t any approved agents for maintenance treatment in platinum-sensitive relapsed ovarian cancer, which is defined as a relapse that occurs more than six months from the date of the last dose of platinum-based chemotherapy.
Though the drug failed to win support from the FDA panel for accelerated approval, AstraZeneca said it is continuing with a Phase III program to evaluate the benefits of olaparib. It aims to complete that study by the end of 2015.
