The FDA has granted approval to voranigo, making it the first drug approved in the U.S. for the treatment of Grade 2 IDH-mutant glioma, a type of brain tumor. The approval is specifically for patients who have undergone surgery to remove the tumor.
Grade 2 IDH-mutant glioma is a type of brain tumor caused by mutations in the isocitrate dehydrogenase (IDH) gene family. In the U.S., the incidence of this condition is approximately 0.7 cases per 100,000 people. Until now, surgical removal of the tumor has been the primary treatment option for Grade 2 IDH-mutant glioma.
The FDA's approval of voranigo was based on the results of a late-stage clinical trial. Patients who received voranigo demonstrated a progression-free survival of 27.7 months, compared to 11.1 months in the placebo group, indicating a significant improvement in the management of this condition.
