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Oncologic Drugs Advisory Committee

During the morning session, the committee will discuss new drug application (NDA) 211810 for pexidartinib capsule, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adult patients with symptomatic tenosynovial giant cell tumor, also referred to as giant cell tumor of the tendon sheath or pigmented villonodular synovitis, which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery.

During the afternoon session, the committee will discuss NDA 212166 for quizartinib tablets, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory acute myeloid leukemia, which is FLT3-ITD positive, as detected by an FDA-approved test.