Safety concerns over the PARP inhibitor warranted the request for additional data.
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.
The panel voted 11-2 that the company should complete a second trial to confirm results seen in a smaller study which, while positive, were not robust enough to convince the committee that they could be reproduced. 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. Olaparib is one of several cancer drugs AstraZeneca flagged as having strong potential in its defense of a $118 billion take-over bid by Pfizer Inc.