Shots:
- The EC has approved Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery, but do not currently require radiotherapy or CT across EEA states
- Approval was based on the global pivotal P-III (INDIGO) trial, which demonstrated that vorasidenib significantly improved PFS and TTNI vs PBO The median PFS (27.7mos. vs 11.1mos.), and TTNI was also significantly prolonged, with the mTTNI not reached vs 17.8mos. An exploratory EP showed reduced tumor volume by an average of 2.5% vs 13.9% every 6mos.
- Safety profile consistent with P-I studies. Published in The NEJM and presented at the ASCO’23
Ref: PRNewsWire | Image: Servier| Press Release
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