FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant Diffuse Glioma
News of Enormous Potential for IDH-mutant Glioma Patients
Within the past 24 hours, Servier reported that it has submitted both a New Drug Application (NDA) to the US FDA and a Marketing Authorization Application (MAA) to the EMA for the accelerated assessment and potential approval of vorasidenib (see here) to treat IDH-mutant gliomas. The FDA PDUFA date for the NDA is August 20, 2024 and European Commission approval is anticipated for the second half of 2024.
As we posted on MissionGBM in June-2023, the pivotal clinical data from the INDIGO trial was compelling and supported worldwide regulatory submissions for approval (see here).
Assuming regulatory approval, we have little doubt that vorasidenib will improve the treatment paradigm for IDH-mutant LGGs (Grades 2 and 3). We will be very interested in eventually seeing the Real World clinical data for higher grade gliomas (Grades 3+ and 4) treated with vorasidenib as part of the overall regimen for these more aggressive brain tumors.