The FDA has approved Tibsovo® (ivosidenib tablets) in combination with azacitidine for the treatment

Release date: 2025-12-31 11:51:41     Recommended: 163

Tibsovo® (ivosidenib tablets) is the first tumor metabolism-targeted therapy approved for use in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) harboring an IDH1 mutation. This FDA approval was based on data from the global Phase III AGILE trial, which demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS).

On May 25, 2022, Servier, a leader in oncology dedicated to bringing future hope to patients, announced that the U.S. Food and Drug Administration (FDA) had approved Tibsovo® (ivosidenib tablets) in combination with azacitidine for the treatment of adult patients aged 75 years or older, or those with comorbidities who are ineligible for intensive induction chemotherapy, and have newly diagnosed IDH1-mutated acute myeloid leukemia (AML). Tibsovo® is the first tumor metabolism-targeted therapy approved in combination with azacitidine for this patient population. The AGILE trial is the only Phase III trial specifically designed for newly diagnosed IDH1-mutated AML patients who are not candidates for intensive chemotherapy.

The supplemental New Drug Application (sNDA) for Tibsovo® was granted Priority Review designation and reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which is designed to ensure that patients have timely access to safe and effective treatments.

"Today’s approval builds on the substantial existing evidence for Tibsovo®, which is now approved for the treatment of multiple IDH1-mutated cancer types," said David K. Lee, Chief Executive Officer of Servier Pharmaceuticals. "As a leader in oncology, we are at the forefront of scientific exploration in targeted IDH inhibition. We are proud to bring a new treatment option to the AML community and remain committed to pushing the boundaries of innovation in oncology and broader healthcare."

In the United States, Tibsovo® is also approved as a monotherapy for adult patients with relapsed or refractory IDH1-mutated AML, as well as for newly diagnosed IDH1-mutated AML adult patients aged 75 years or older or those ineligible for intensive induction chemotherapy due to comorbidities. Last year, Tibsovo® secured its first approval in a non-hematologic malignancy, indicated for the treatment of previously treated IDH1-mutated cholangiocarcinoma patients.