Ivosidenib Receives FDA Priority Review for New Indication in IDH1-Mutant MDS; CStone Pharmaceuticals Holds Exclusive Rights in Greater China and Singapore

On August 15, Servier announced that the FDA has accepted and granted priority review for the new indication application of TIBSOVO (ivosidenib) for the treatment of IDH1-mutant relapsed or refractory (R/R) myelodysplastic syndromes (MDS). If approved, ivosidenib will become the first targeted therapy for treating IDH1-mutant MDS.

Ivosidenib is the first oral small-molecule inhibitor precisely targeting IDH1 mutations. In July 2018, based on the positive results of the AG120-C-001 study, the FDA approved ivosidenib for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) carrying IDH1 mutations, making it the world's first approved IDH1 inhibitor.

The marketing application for this new indication is based on the positive results from a pivotal Phase I open-label study of ivosidenib in patients with IDH1-mutated R/R MDS. The study demonstrated significant efficacy of ivosidenib, with a complete response rate (CR) of 38.9% and an objective response rate (ORR) of 83.3%. Additionally, ivosidenib treatment showed a favorable safety profile.

It is worth mentioning that CStone Pharmaceuticals has obtained exclusive rights from Servier to develop and commercialize ivosidenib in the Greater China region, including mainland China, Hong Kong, Taiwan, and Macau, as well as in Singapore.

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