Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia

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 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.

Of the 11 patients with newly diagnosed AML who experienced differentiation syndrome with TIBSOVO plus azacitidine, 8 (73%) recovered.

Of the 7 patients with newly diagnosed AML who experienced differentiation syndrome, 6 (86%) patients recovered.