FDA approves sNDA for Tibsovo

The US Food and Drug Administration has approved Agios Pharmaceuticals’ (Nasdaq: AGIO) supplemental New Drug Application (sNDA) for Tibsovo (ivosidenib) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have co-morbidities that preclude the 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.

“Despite several new AML medicines approved in the last two years, many newly-diagnosed patients are still not eligible for existing therapies or combination regimens because of age and other co-morbidities,” said Dr Chris Bowden, chief medical officer at Agios.