FDA Approves Rigel Pharmaceuticals’ Rezlidhia for AML With IDH1 Mutation

The FDA has approved Rigel Pharmaceuticals’ Rezlidhia (olutasidenib) for the treatment of adult patients with relapsed or resistant acute myeloid leukemia (AML) with a susceptible IDH1 mutation.

Rezlidhia is an oral IDH1 inhibitor and works by lowering 2-hydroxyglutarate levels — an indicator of tumors with an IDH1 mutation — and restore differentiation of myeloid cells to normalcy.

Agency approval was based on a study that Rezlidhia met the primary endpoint, demonstrating complete remission plus complete remission with partial hematologic recovery in 35 percent of patients, with a median duration of response of 25.9 months.

The drug is part of a licensing deal inked between Rigel and Forma Therapeutics in August.