Servier announced that the U.S. Food and Drug Administration (FDA) has approved Tibsovo® (ivosidenib

On October 24, 2023, Servier, a leader in the oncology field dedicated to bringing tomorrow’s hope to patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Tibsovo® (ivosidenib tablets) for the treatment of patients with relapsed or refractory myelodysplastic syndromes (MDS) harboring an isocitrate dehydrogenase-1 (IDH1) mutation. This marks the fifth indication of Tibsovo in IDH1-mutant cancers, and it is also the first and only targeted therapy approved for the treatment of patients with relapsed or refractory myelodysplastic syndromes diagnosed in this molecularly defined subtype.

Arjun Prasad, Head of Commercial at Servier Pharmaceuticals, stated: “We are proud that Servier is committed to supporting patients with hard-to-treat cancers through continuous innovation and leading the advancement in the field of IDH-mutant inhibition. As the first and only targeted therapy available for patients with IDH1-mutant relapsed or refractory myelodysplastic syndromes, today’s FDA approval of Tibsovo further reinforces our commitment to making significant progress in areas of high unmet medical need and delivering the right treatment to the right patient at the right time.”

The FDA’s approval of this indication was primarily based on a groundbreaking Phase 1, open-label study (n=18) in patients with IDH1-mutant relapsed or refractory myelodysplastic syndromes. The study demonstrated that patients treated with Tibsovo achieved a complete response (CR) rate of 38.9% and an objective response rate (ORR) of 83.3%. Additionally, the median time to complete response was 1.9 months (range: 1.0–5.6 months). At the time of data cutoff, the median duration of complete response had not been reached (range: 1.9–more than 80.8 months), and the median overall survival (OS) was 35.7 months (range: 3.7–88.7 months).

Among the 9 patients who were dependent on red blood cell or platelet transfusions at baseline, 66.7% (n=6) achieved transfusion independence for any period of ≥56 days after baseline. Overall, treatment-related adverse events were consistent with the known safety profile of Tibsovo.

Tibsovo is a precision medicine that targets a specific type of mutation—the isocitrate dehydrogenase-1 (IDH1) mutation. To date, Tibsovo has been approved for five indications worldwide, including approvals in the United States, the European Union, Australia, and China.