FDA expands approval of Servier leukemia drug

May 27, 2022

The FDA has expanded the approval of Servier’s Tibsovo, the first therapy targeting cancer metabolism for patients with newly diagnosed leukemia. 

Tibsovo was initially approved in 2018 for the treatment of patients with acute myeloid leukemia with a susceptible IDH1 mutation. In 2021, approval was expanded to include the treatment of patients with IDH1-mutant cholangiocarcinoma.

Now, supported by data from the Boston-based pharma company's AGILE phase 3 trial, Tibsovo can be used in combination with azacitidine for the treatment of newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. The study met its primary endpoint of event-free survival, with secondary endpoint goals of complete remission, and overall survival. 

The recent approval makes Tibsovo the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML.

AML is a blood and bone marrow cancer, characterized by rapid disease progression and 20,000 new cases in the U.S., and 43,000 cases in Europe are reported each year.

The drug's supplemental New Drug Application was reviewed by the FDA under its Real-time Oncology Review pilot program, whose goal is to streamline effective and safe treatments for patients by attempting to make them available as early as possible.