US FDA approves Servier's brain tumor treatment 

[August 07, 2024]  (Reuters) - Servier Pharmaceuticals said on Tuesday the U.S. Food and Drug administration has approved the French drugmaker's treatment for a type of brain tumor, making it the first drug to get a U.S. approval for the condition.

The drug, branded as voranigo, is used to treat a form of brain cancer, called Grade 2 IDH-mutant glioma, in patients who have had surgery.

Gliomas, types of brain cancer that can hinder normal brain function, are so far only treated through the removal of the tumor. Grade 2 IDH-mutant glioma is caused by mutations in a family of genes called isocitrate dehydrogenase or IDH.

Voranigo was approved on the basis of a late-stage trial, where patients who took the treatment showed progression-free survival of 27.7 months compared to 11.1 months with the placebo group.

In the U.S., about 0.7 of every 100,000 people suffer from IDH-mutant glioma.

With the approval, Agios Pharmaceuticals will receive up to $1.1 billion in milestone payments from Servier and Royalty Pharma.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

In 2021, Agios sold its oncology business to Servier and received $1.8 billion in upfront cash. It was also set to get a $200 million milestone payment upon the FDA approval of voranigo and 15% royalties on the drug's potential U.S. net sales.

In May this year, Agios sold some of its voranigo royalty rights to Royalty Pharma. Under the terms of the agreement, an FDA approval for the drug would trigger a payment of $905 million to Agios.

(Reporting by Christy Santhosh; Editing by Shilpi Majumdar)

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