Daiichi gets ODAC split, with FDA panel backing pexidartinib for rare cancer

Missing data and lingering safety questions dogged a pair of Daiichi Sankyo oncology agents that came before ODAC on Tuesday, but a lack of available treatment options for tenosynovial giant cell tumor and a clear win on the primary endpoint for pexidartinib swayed the FDA panel in favor of approval 12-3. Quizartinib, to treat relapsed, refractory FLT3-ITD-positive AML, did not fare as well, with the Oncologic Drugs Advisory

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