FDA panel recommends more clinical data on AstraZeneca drug

By Toni Clarke WASHINGTON (Reuters) - An advisory panel to the U.S. Food and Drug Administration recommended on Wednesday that AstraZeneca Plc be required to submit further clinical data before its experimental ovarian cancer drug is approved. Panel members expressed concern about a potential increased risk of secondary cancers in patients receiving the drug, olaparib, as well as side effects such as nausea and gastrointestinal disturbances. The FDA is not obliged to follow the advice of its advisory panels but typically does so. "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," Briggs Morrison, chief medical officer at AstraZeneca, said.



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