Rigel : FDA Oks REZLIDHIA For Treatment Of R/R Acute Myeloid Leukemia With Susceptible IDH1 Mutation

(RTTNews) - Rigel Pharmaceuticals Inc. (RIGL) said that the U.S. Food and Drug Administration has approved REZLIDHIA or olutasidenib capsules for the treatment of adult patients with relapsed or refractory or R/R acute myeloid leukemia or AML with a susceptible isocitrate dehydrogenase-1 or IDH1 mutation as detected by an FDA-approved test.

REZLIDHIA is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.

In August 2022, Rigel and Forma Therapeutics announced they entered a license agreement to develop, manufacture and commercialize REZLIDHIA. As per the terms of the agreement, Rigel will be responsible for the launch and commercialization of REZLIDHIA in the U.S., and intends to work with potential partners to further develop and commercialize the product outside the U.S.