The U.S. Food and Drug Administration's (FDA) staff on Tuesday raised concerns over the safety of Spectrum Pharmaceutical's experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 30%.
The corporate logo of the U.S. Food and Drug Administration is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly. REUTERS/Jason ReedSept 20 - The U.S.
experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 30%. The concerns over poziotinib were raised in the regulator's briefing documents ahead of a meeting of its external advisers on Thursday. The reviewers cited lack of clarity on whether poziotinib provided enough duration of response in treating a type of non-small cell lung cancer, compared with existing drugs like Daiichi Sankyo's
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