ODAC to discuss Daiichi Sankyo's pexidartinib, quizartinib NDAs

FDA’s Oncologic Drugs Advisory Committee will meet on May 14 to discuss two NDAs from Daiichi Sankyo, one for pexidartinib to treat symptomatic tenosynovial giant cell tumors and the other for quizartinib to treat relapsed or refractory FLT3-internal tandem duplication (ITD) mutation-positive acute myelogenous leukemia (AML).

Pexidartinib is a small molecule inhibitor of CSF1R, c-Kit and FLT3. Quizartinib is a small molecule FLT3 inhibitor...