FDA Grants Accelerated Approval to Modeyso for Recurrent H3 K27M-Mutant DMG

Published on LinkedIn via Spencer Knight

The FDA has given accelerated approval to Jazz Pharmaceuticals’ Modeyso (dordaviprone) for recurrent H3 K27M-mutant diffuse midline glioma, the first systemic option for this rare and aggressive brain tumor. Pooled Phase 2 data showed a 22% overall response rate and a 10.3-month median duration of response, with 73% of responders benefiting for at least six months. A confirmatory Phase 3 trial (ACTION) is in progress.

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