Posted by Michael Wonder on 21 Feb 2024
FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant improvements in progression-free survival and time-to-next intervention.
Servier today announced the FDA filing acceptance and priority review for a new drug application for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib marketing authorisation application.
