TIBSOVO's Potential: Susan Pandya, MD, on FDA Priority Review for IDH1-Mutated MDS

Delve into the transformative potential of TIBSOVO in revolutionizing the treatment landscape for IDH1-mutated myelodysplastic syndromes (MDS). In a comprehensive interview, Susan Pandya, MD, provides valuable insights into the FDA's priority review.


In the interview, Susan Pandya, MD, Vice President of Clinical Development at Servier Pharmaceuticals, discusses the pivotal FDA acceptance and priority review for TIBSOVO in the treatment of IDH1-mutated relapsed or refractory myelodysplastic syndromes (MDS). The acceptance marks a significant milestone in advancing targeted therapies for patients facing limited options in this challenging disease context.

TIBSOVO's clinical data submission showcased remarkable results, with complete remissions achieved in approximately 40% of patients and an overall response rate of 83.3% among those with relapsed or refractory IDH1-mutated MDS. These outcomes far exceed existing treatment options, underscoring TIBSOVO's potential as a transformative therapy for this patient population.

The potential approval of TIBSOVO as the first targeted therapy for IDH1-mutated MDS patients holds promise for improving their outcomes. It offers hope to the 3.6% of diagnosed patients who harbor this mutation and have historically faced limited treatment options, providing a pathway to enhanced survival rates and improved quality of life.