October 24, 2023, Boston, USA
Servier announced that the U.S. Food and Drug Administration (FDA) has approved ivonidenib for the treatment of patients with relapsed or refractory (R/R) myelodysplastic syndrome (MDS) due to isocitrate dehydrogenase 1 (IDH1) mutations. This is the fifth indication for ivonidenib in IDH1-mutant cancers, and the first and only approved targeted therapy for this molecularly defined subgroup of R/RMDS patients.
Arjun Prasad, Head of Commercial Development at Servier Pharmaceuticals, stated, "Servier is proud to lead the development of IDH mutation inhibitors through continuous innovation to support patients with refractory cancers. The approval of Ivosidenib today, as the first and only targeted therapy for patients with IDH1-mutant relapsed or refractory MDS, confirms our commitment to achieving significant breakthroughs in areas of high unmet need, providing the right treatment to the right patients at the right time."
Expert Opinion
Dr. Amir Fathi, a hematologic oncology expert, pointed out, "The innovative application of targeted therapy in IDH-mutant cancers has become an important treatment for patients with this molecular subtype." Choice. This approval of a new indication highlights the crucial value of gene mutation testing in treatment decisions and improving prognosis.
"Previously, there were no targeted therapies available for patients with IDH1-mutant R/RMDS. This approval is a major boon for the patient community. We sincerely thank the participants, their families, nurses, and researchers for their contributions to this groundbreaking advancement."
About Ivosidenib
Ivosidenib is the world's first precision therapy targeting IDH1 mutations, currently approved for five indications globally (including in the US, EU, Australia, and China).
US Indications
1. Monotherapy for adult patients with relapsed or refractory IDH1-mutant AML
2. Monotherapy or in combination with azacitidine for newly diagnosed adult patients ≥75 years of age or who cannot tolerate intensive chemotherapy
3. Monotherapy for adult patients with relapsed or refractory IDH1-mutant MDS
4. Treatment of previously treated patients with IDH1-mutant cholangiocarcinoma
Servier has granted CStone Pharmaceuticals co-development rights and exclusive commercialization licenses in Mainland China, Taiwan, Hong Kong, Macau, and Singapore.
