FDA Approves Tibsovo Plus Vidaza For Patients With Newly Diagnosed Acute Myeloid Leukemia

The Food and Drug Administration has approved the combination of Tibsovo (ivosidenib tablets) and Vidaza (azacitidine) for patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are 75 years or older or have comorbidities that precludes intensive induction chemotherapy.

According to a press release, Tibsovo is the first therapy targeting cancer metabolism approved in combination with Vidaza for this patient population.

“… Tibsovo is the first therapy targeting cancer metabolism to demonstrate an impressive, significant benefit in event-free survival and overall survival in combination with (Vidaza), underscoring its importance as part of a new combination regimen for patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are not candidates for intensive induction chemotherapy,” said Dr. Eytan M. Stein, director of Program Medicine at Memorial Sloan Kettering Cancer Center, in the release.

The approval comes following results of the AGILE trail which demonstrated a statistically significant improvement in progression-free survival (time during and after treatment when the patient lives without disease progression) and overall survival (time from treatment until death of any cause). Specifically, the approved combination resulted in a threefold improvement in median overall survival (24 months) compared to placebo plus Vidaza (7.9 months).

The most common side effects occurred in 10% of patients and included nausea, vomiting, electrocardiogram QT prolonged (heartbeat taking longer to recharge between beats), insomnia, differentiation syndrome, leukocytosis (high white blood cell count), hematoma (bad bruising), hypertension, joint stiffness, dyspnea (difficulty breathing) and headache.

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