▎WuXiEdited by Kant Content Team

Servier today announced that the U.S. FDA has accepted its IDH1/2 inhibitor vorasidenib for the treatment of patients with IDH-mutant glioma, granting it Priority Review, while the European Medicines Agency (EMA) has also approved the accelerated assessment of vorasidenib's Marketing Authorization Application (MAA).According to the press release, if approved, vorasidenib will become the "first-in-class" targeted therapy for patients with IDH-mutant glioma and will mark Servier's sixth approved indication in the field of IDH-mutant cancers.The FDA has set a PDUFA target date of August 20, 2024 for this application, while the European Commission is expected to announce its review results in the second half of 2024.

The submission of the marketing application is primarily based on the results of the INDIGO pivotal Phase 3 clinical trial, which met the primary endpoint of progression-free survival (PFS) assessed by the blinded independent review committee (BIRC) and the key secondary endpoint of time to next intervention (TTNI) at the second pre-specified interim analysis.PFS assessed by BIRCAnalysis shows,The PFS for patients in the vorasidenib group and placebo group were 27.7 months and 11.1 months, respectively, reaching the primary endpoint of the trial, with a significant difference between the two.With statistical significance and clinical importance (HR=0.39; 95% CI: 0.27-0.56; one-sided P=0.000000067)。

In the assessment of secondary endpoints, the median TTNI has not yet been reached in the vorasidenib group, compared to 17.8 months in the placebo group, with statistically significant differences (HR=0.26; 95% CI: 0.15-0.43; one-sided P=0.000000019). Additionally, analysis showed that, according to measurements by the blinded independent radiology committee,Vorasidenib reduced tumor volume by an average of 2.5% every 6 months, while the placebo group experienced an average increase of 13.9%.

The INDIGO study showed that vorasidenib was well tolerated, with a safety profile consistent with the results from previous Phase 1 studies.

▲Chemical structure of Vorasidenib (Image source: PubChem)

Vorasidenib is an orally available, brain-penetrant, and selective investigational dual inhibitor that inhibits mutant IDH1/2 proteins, representing a potential “first-in-class” drug.It has been granted Breakthrough Therapy Designation by the U.S. FDA.

Everyone is watching

▲If you have any business needs, please long press to scan the QR code above, or click "Read more" at the end of the article to access the business对接 platform and fill in your business needs information.

▲ To learn more about the application of cutting-edge technologies in the biopharmaceutical industry, please long press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.