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US FDA approves Servier's brain tumor treatment
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US FDA approves Servier's brain tumor treatment
Aug 6, 2024 4:45 PM

Aug 6 (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 ( AGIO ) will

receive up to $1.1 billion in milestone payments from Servier

and Royalty Pharma ( RPRX ).

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 ( RPRX ). Under the terms of the agreement, an

FDA approval for the drug would trigger a payment of $905

million to Agios.

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