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Quizartinib Receives Orphan Drug Designation for FLT3-Mutated AML in Japan

Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan

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TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018  — The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.

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Ribociclib FDA label updated to include pre- and perimenopausal women©United States Food and Drug Agency

Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia

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On July 20, 2018, the US FDA approved ivosidenib (Tibsovo©, Agios Pharmaceuticals) for use in adult patients with relapsed or refractory acute myeloid leukaemia (AML) harbouring a susceptible IDH1 mutation as detected by an FDA-approved companion diagnostic (CDx) test, the Abbott RealTime IDH1 Assay.

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