FDA & Government News

FDA Approves Voranigo for Grade 2 IDH-Mutant Glioma

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The FDA's approval of voranigo marks a significant milestone as it becomes the first drug approved in the U.S. for the treatment of Grade 2 IDH-mutant glioma, a type of brain tumor. This approval is specifically for patients who have undergone surgery to remove the tumor. Grade 2 IDH-mutant glioma is caused by mutations in the isocitrate dehydrogenase (IDH) gene family, with an incidence of approximately 0.7 cases per 100,000 people in the U.S. Voranigo demonstrated a substantial improvement in the management of this condition, with patients showing a progression-free survival of 27.7 months in a late-stage clinical trial, compared to 11.1 months in the placebo group.

Original Source(s)

FDA Approves Voranigo for Grade 2 IDH-Mutant Glioma

  • by Christy Santhosh

  • August 7, 2024

  • 1 min

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