Servier Pharmaceuticals announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted approval for its brain tumor treatment, marking the first drug to receive U.S. approval for this specific condition.
The drug, branded as Voranigo, is designed to treat Grade 2 IDH-mutant glioma, a type of brain cancer that typically occurs after surgery. This form of glioma is caused by mutations in the isocitrate dehydrogenase (IDH) gene family. Gliomas can significantly impair normal brain function and are currently managed primarily through tumor removal.
Voranigo’s approval is based on positive results from a late-stage clinical trial, which demonstrated that patients receiving the drug experienced a progression-free survival rate of 27.7 months, compared to 11.1 months for those receiving a placebo.
In the U.S., approximately 0.7 out of every 100,000 individuals are affected by IDH-mutant glioma.
Following this approval, Agios Pharmaceuticals will receive up to $1.1 billion in milestone payments from Servier and Royalty Pharma. Agios, which sold its oncology division to Servier in 2021 for $1.8 billion, was also set to receive a $200 million milestone payment upon FDA approval of Voranigo, along with 15% royalties on the drug’s potential U.S. net sales.
Earlier this year, in May, Agios sold some of its Voranigo royalty rights to Royalty Pharma. According to the agreement, the FDA’s approval of Voranigo triggers a $905 million payment to Agios.
