FDA approves sNDA for Tibsovo to treat newly diagnosed patients with IDH1 Mutant AML not eligible for intensive chemotherapy.- Agios Pharma

Agios Pharmaceuticals, Inc.has announced the FDA approved a supplemental New Drug Application (sNDA) to update the U.S. Prescribing Information for Tibsovo, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved testand who are greater than 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

The sNDA was granted Priority Review and accepted under the FDA's Real-Time Oncology Review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency. Tibsovo received initial FDA approval in July 2018 for adult patients with relapsed or refractory (R/R) AML and an IDH1 mutation.