June 25 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 trial which,
while positive, were not robust enough to convince the committee
that they could be reproduced.
Panel members also expressed concern about a potential
increased risk of secondary cancers in patients receiving the
drug, olaparib. The FDA is not obliged to follow the advice of
its advisory panels but typically does so.
(Reporting by Toni Clarke in Washington; Editing by Bill Trott)