FDA approves Rigel's olutasidenib for AML

Well ahead of expectations, on December 1, the US Food and Drug Administration (FDA) approved Rezlidhia (olutasidenib) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

The FDA accepted Forma Therapeutics’ New Drug Application (NDA) for olutasidenib in August this year, setting a Prescription Drug User Fee Act (PDUFA) target action date of February 15, 2023.

Since then, Forma entered into licensing deal with Rigel Pharmaceuticals (Nasdaq: RIGL), granting the US biotech launch and commercialization rights to olutasidenib in the USA. Rigel said it intends to work with potential partners to further develop and commercialize the product outside the USA. Rigel’s shares rocketed up 44% to $0.98 in pre-market trading today.