Servier announced that the U.S. 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 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 3 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.1
AML is a difficult-to-treat cancer of the blood and bone marrow and is one of the most common types of leukemia in adults with approximately 20,000 new cases estimated in the U.S. each year.3,4 IDH1 mutations are present in about 6 to 10 percent of AML cases.5
The combination of TIBSOVO plus azacitidine demonstrated a safety profile consistent with previously published data. The most common adverse reactions (≥10%) in newly diagnosed AML patients receiving TIBSOVO in combination with azacitidine were nausea, vomiting, electrocardiogram QT prolonged, insomnia, differentiation syndrome, leukocytosis, hematoma, hypertension, arthralgia, dyspnea, and headache. The select laboratory abnormalities (≥10%) were leukocytes decreased, platelets decreased, hemoglobin decreased, neutrophils decreased, lymphocytes increased, glucose increased, phosphate decreased, aspartate aminotransferase increased, magnesium decreased, alkaline phosphatase increased, and potassium increased.