(Reuters) – The U.S. Food and Drug Administration’s (FDA) staff raised concerns over the safety of Spectrum Pharmaceutical’s experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 32% in premarket trade.
The staff’s concerns over poziotinib were raised in the regulator’s briefing documents ahead of a meeting of its external advisers on Thursday.
(Reporting by Leroy Leo in Bengaluru; editing by Uttaresh.V)