FDA Requests More Data For AstraZeneca Ovarian Cancer Drug

An FDA advisory panel has recommended that AstraZeneca submit further clinical data on its experimental ovarian cancer drug olaparib before an approval is granted in the U.S. Last week, the panel voted 11-2 in favor of having AstraZeneca complete a second trial. The FDA noted that while the results of the first olaparib trial were positive, the study was too small and the panel was not convinced that the data could be readily reproduced.

It should be noted that while the advisory panel’s recommendation holds strong weight with the FDA, the FDA is not mandated to follow through with their advice. In particular, the panel members were concerned about the possible increased risk of patients developing secondary cancers. Some patients also developed adverse side effects, such as nausea and gastrointestinal problems.

AstraZeneca has stated that it will continue to work on developing olaparib, with a Phase III clinical trial scheduled to be completed by the end of 2015. Briggs Morrison, chief medical officer at AstraZeneca, commented on the FDA’s recommendation. “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,” said Morrison.

Olaparib inhibits the activity of a key enzyme in cell-repair, Poly (ADP-ribose) polymerase (PARP). The drug’s target patients are women with BRCA gene mutations, which are responsible for 10-15 percent of ovarian cancer cases. Investors considered olaparib to be one of AstraZeneca’s stronger drugs in its portfolio. The strength of AstraZeneca’s cancer drug portfolio was rumored to be one of the reasons that Pfizer was attempting to acquire the company earlier this year.

Ovarian cancer is the fifth leading cause of cancer death of women living in the U.S. In 2014, there has already been 22,000 new diagnosed cases and 14,270 deaths related to the disease.