Daiichi Sankyo 'disappointed' as FDA experts spurn AML drug but vote in favor of rare tumor drug
Daiichi Sankyo has offered up the freshest case study of just where the line is drawn on cancer drugs showing incremental — or even questionable — benefits, as critical internal reviews from the FDA translated into differing advisory committee opinions on two of its pitches.
By a 3-8 margin, the oncology experts convened by the agency shot down the Japanese drugmaker’s case for its acute myeloid leukemia drug quizartinib, having voted in favor of pexidartinib in the morning session. Pexidartinib treats benign tumors known as symptomatic tenosynovial giant cell tumor.
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