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.