Breaking News: FDA Approves Vorasidenib (Voranigo®)

A great day for Low Grade Astrocytoma and Oligodendroglioma Patients with IDH1/IDH2 Mutations

UPDATE: A few hours after we originally posted, Servier updated its Home page and issued a press release about the Vorasidenib approval. See here for further information.

We have had 20-Aug-2024 circled on our calendar for months because it was the PDUFA date for vorasidenib.  Just over one hour ago, FDA delivered an upside surprise and issued an approval two weeks early for vorasidenib (Voranigo®; see here) for low grade Astrocytoma and Oligodendroglioma patients with IDH1/IDH2 mutations based on compelling results from the pivotal INDIGO clinical trials (see here).

Warmest Congratulations to the Servier and Agios teams that discovered and developed vorasidenib over many years.  Many thanks to the patients and investigators whose participation in clinical trials made today’s approval possible.

Onward!