FDA approves Servier's Tibsovo sNDA

French privately-held drugmaker Servier has announced that the US Food and Drug Administration (FDA) approved Tibsovo (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Tibsovo, rights to which Servier acquired under a $2 billion deal with Agios Pharmaceuticals (Nasdaq: AGIO) in 2020, is the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML. The AGILE trial was the only Phase III trial designed specifically for newly diagnosed patients with IDH1-mutated AML who are ineligible for intensive chemotherapy.

The supplemental New Drug Application (sNDA) for Tibsovo received Priority Review and was reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.