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FDA advisors reject one Daiichi Sankyo cancer drug, back another

May 15, 2019 / Richard Staines

Daiichi Sankyo had a day of mixed fortunes after advisers to the US regulator voted against approval for its leukaemia drug quizartinib, but recommended pexidartinib for a rare tumour. Experts from the FDA’s Oncologic Drugs Advisory Committee (ODAC) met to discuss clinical data from the two drugs, and made non-binding recommendations ahead of the decision date set for them.
While these are only recommendations, the FDA usually follows the advice of its advisory committees. The Japanese pharma is seeking approval for quizartinib to treat patients with relapsed/refractory FLT3-ITD acute myeloid leukaemia (AML). But the committee voted against approval by eight votes to three, unconvinced by the results from the phase 3 QuANTUM-R study. Committee members agreed with FDA reviewers who raised concerns that although the study hit its target of a statistically significant improvement in overall survival, the study design may have biased the results. This was because there was a m...