The U.S. FDA has approved Tibsovo® (ivosidenib – Servier) for use in combination with azacitidine to treat newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults who are at least 75 years old or have comorbidities that preclude use of intensive induction chemotherapy.

• Tibsovo is also indicated to treat relapsed or refractory AML and locally advanced or metastatic cholangiocarcinoma. It first received FDA approval in 2018.
• Recommended dosing is 500mg of Tibsovo taken by mouth once daily until disease progression or unacceptable toxicity occur. Patients should avoid taking Tibsovo with a high fat meal, as it can affect how the medication works.