Skip to main content
Premium Trial:

Request an Annual Quote

FDA Approves Rigel Pharmaceuticals' Rezlidhia for IDH1-Mutant AML

NEW YORK – The US Food and Drug Administration on Thursday approved Rigel Pharmaceuticals' IDH1 inhibitor Rezlidhia (olutasidenib) as a treatment for relapsed or refractory acute myeloid leukemia patients whose cancers harbor susceptible IDH1 mutations.

The FDA simultaneously approved Abbott Laboratories' RealTime IDH1 Assay as a companion diagnostic to identify patients with IDH1 mutations who are eligible for Rezlidhia treatment.

The agency based its approval on the results of the Phase II 2102-HEM-101 clinical trial in which 147 patients with relapsed or refractory IDH1-mutated AML received Rezlidhia. In that trial, 32 percent of patients experienced a complete remission and 2.7 percent experienced a complete remission with partial hematologic recovery, which the investigators defined as less than 5 percent blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts.

The median duration of complete remission or complete remission plus partial hematologic recovery was 25.9 months.

Rigel inked a deal with Forma Therapeutics in August, which gives Rigel the rights to develop and commercialize Rezlidhia in the US. The South San Francisco, California-headquartered firm is working with partners to develop and commercialize the agent in other regions.