US FDA approves Servier’s brain tumor treatment
US FDA approves Servier’s brain tumor treatment
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.O) will receive up to $1.1 billion in milestone payments from Servier and Royalty Pharma (RPRX.O).
Reuters
Reuters