Agios Pharmaceuticals announces FDA approval of sNDA for TIBSOVO

Agios Pharmaceuticals announced the U.S. Food and Drug Administration approved a supplemental New Drug Application to update the U.S. Prescribing Information for TIBSOVO, an isocitrate dehydrogenase-1 inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test who are greater than or equal to 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. TIBS7OVO received initial FDA approval in July 2018 for adult patients with relapsed or refractory AML and an IDH1 mutation.

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