Servier Submits New Indication Application for Ivosidenib in China for First-Line Treatment of IDH1-Mutant AML

Mar 27, 2025 11:04 CST Updated 11:04

Servier

International Pharmaceutical Manufacturers

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Today (March 25),The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA),The new indication marketing application for ivosidenib tablets, a Class 5.1 new drug submitted by Servier, has been accepted. Public information shows that ivosidenib tablets (ivosidenib) areA treatment forIDH1Oral Targeted Inhibitors of Mutant Enzymes. This product has been previously approved by China's NMPA as a "clinically urgently needed overseas new drug" for the treatment ofCarryIDH1Adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring susceptible mutations。

Based on the progress of clinical research in China, the indication for this product's marketing application may beCombination of Azacitidine as First-Line Treatment for Patients with SusceptibilityIDH1AML patients with mutations。

Screenshot source:CDE Official Website

Ivosidenib tablets are a targeted treatment forIDH1An oral targeted inhibitor of mutant enzymes. The product has been granted Fast Track designation and Orphan Drug designation by the U.S. FDA, and was first approved by the FDA in July 2018. In China, the product was included in the "Third List of Overseas New Drugs Urgently Needed Clinically" in November 2020, and received conditional approval from the Chinese NMPA through the priority review and approval process in January 2022. In August 2024, the product was also shortlisted for the 2024 Prix Galien Award.

In the United States, the drug has currently been approved for use in patients identified as carriers of susceptibility through an FDA-approved test.IDH1Patients with mutations, including:In combination with azacitidine or as monotherapy for patients aged 75 years or older or those with comorbidities who are ineligible for intensive induction chemotherapyNewly Diagnosed AML in Adults; MonotherapyAdult patients with relapsed or refractory AML; TreatmentRecurrent or RefractoryMyelodysplastic Syndromes (MDS)Adult patients;Previously treated locally advanced or metastaticCholangiocarcinomaAdult patients.In China, ivosidenib has been approved for the treatment of patients with susceptibleIDH1Adult patients with relapsed or refractory AML harboring mutations.

According to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, researchers have launched a Phase 3, randomized, double-blind, placebo-controlled multicenter study in China, with the target population beingIDH1Patients with mutated acute myeloid leukemia who have not been treated, compared with the combination of azacitidine and placebo,Combination of Ivosidenib Tablets and AzacitidineWhether it can significantly prolong the overall survival (OS) of patients. The study was conducted across 20 countries and regions worldwide,Patient recruitment has been completed.。

For first-line treatment carryingIDH1AML Indication with Mutation, Ivosidenib Tablets Received FDA Approval in 2022Approval. This approval is supported by data from the global Phase 3 clinical trial AGILE.This is a global Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial, and the results have been published in The New England Journal of Medicine.Publish.

The test results showed that, compared with chemotherapy,IvosidenibWhen used in combination with azacitidine, it significantly improved patients' event-free survival (EFS).。IvosidenibWhen used in combination with azacitidine, it demonstrated a statistically significant improvement in overall survival (OS).IvosidenibThe median OS in the group was 24.0 months, which is three times that of the control group (7.9 months).In addition, Ivosidenib combined with AzacitidineThe complete response (CR) rate was 47.2%., while the placebo combined with azacitidine was 14.9%. Ivosidenib combined with azacitidineThe rate of complete remission plus complete remission with partial hematologic recovery (CR+CRh) was 52.8%., while the placebo combined with azacitidine group was 17.6%. Ivosidenib combined with azacitidineObjective Response Rate (ORR) was 62.5%, while the placebo combined with azacitidine group was 18.9%.

In addition to the above indications, Servier is also evaluatingIvosidenib Tablets for OtherIDH1The application potential of mutation-related cancer. In January this year, Servier announced updates on the progress of two Phase 3 clinical studies, each evaluatingIvosidenibTargetingIDH1Mutant Conventional Chondrosarcoma, SpecificIDH1Patients with mutant-type myelodysplastic syndromeEfficacy and safety.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Mar 27，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]Servier Announces Expansion of its Tibsovo (ivosidenib) Development Program Investigating its Safety and Efficacy in Patients Living with IDH1-Mutated Cancers in Both Hematological Malignancies and Solid Tumors. Retrieved Jan 9，2025, From https://servier.us/blog/servier-announces-expansion-of-its-tibsovo-ivosidenib-development-program-investigating-its-safety-and-efficacy-in-patients-living-with-idh1-mutated-cancers-in-both-hematological-malignancies-and-so/

[3] Good News! Servier's Toshuwo® Shortlisted for 2024 Prix Galien Award. Retrieved Aug 16，2024, From https://mp.weixin.qq.com/s/oO26302aqMlrJM1-yYICGQ

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