Article
FDA Approval Summary: Vorasidenib for IDH-Mutant Grade 2 Astrocytoma or Oligodendroglioma Following Surgery.
Clinical cancer research : an official journal of the American Association for Cancer Research - 3 Nov 2025
Barbato Michael I, Barone Amy K, Aungst Stephanie L, Miller Claudia P, Ananthula Suryatheja, Bi Youwei, Yang Yuching, Li Xiaoxue, Xiong Ye, Fan Jianghong, Dorff Sarah E, Zhao Hong, Zhou Hua, Pradhan Shan, Scepura Barbara, Sinha Arup K, Stephenson Maritsa, Bhatnagar Vishal, Saber Haleh, Rahman Nam Atiqur, Tang Shenghui, Pazdur Richard, Kluetz Paul G, Larkins Erin, Drezner Nicole
Abstract excerpt
On August 6, 2024, the FDA granted traditional approval to vorasidenib (Voranigo, Servier Pharmaceuticals, LLC) for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase 1 or 2 mutation following surgery, including biopsy, subtotal resection, or gross total resection. The approval was based on data from a...
Read the complete abstract on PubMedTopics
- Humans
- Isocitrate Dehydrogenase
- Astrocytoma