On Tuesday, May 14, 2019, the Oncologic Drugs Advisory Committee (ODAC) met to discuss two new drug applications (NDAs) submitted by Daiichi Sankyo, Inc. (Daiichi Sankyo).
During the morning session, the committee discussed an NDA for Turalio (pexidartinib) capsules, for the proposed indication to treat adults with symptomatic tenosynovial giant cell tumor (TGCT), also referred to as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery. A majority of the committee, twelve of 15 members voted that the demonstrated benefit of pexidartinib outweighs the risks for the proposed use.
During the afternoon session, the committee discussed an NDA for quizartinib tablets, for the proposed treatment of adults with relapsed or refractory acute myeloid leukemia (AML), which is FLT3-ITD positive, as detected by an FDA-approved test. A majority of the committee, eight of 11 members, voted that the results of Study AC220-007 do not demonstrate that treatment with quizartinib provides for a benefit that outweighs the risk in the proposed population. (FLT3 = FMS-like tyrosine kinase 3; ITD = internal tandem duplication)