FDA Schedules ODAC Meetings for Pexidartinib in TGCT and Quizartinib in AML

April 19, 2019 – The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) hearing for May 14, 2019, to discuss a new drug application (NDA) for pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor. The agency also scheduled a meeting for the same date to discuss the NDA for quizartinib tablets for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia … (leggi tutto)