FDA Approves Voranigo for Grade 2 Astrocytoma or Oligodendroglioma

This is the first FDA-approved systemic therapy for patients with a susceptible IDH1 or IDH2 mutation

By Lori Solomon HealthDay Reporter

FRIDAY, Aug. 9, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Voranigo (vorasidenib) for grade 2 astrocytoma or oligodendroglioma with a susceptible mutation.

The isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor is approved for adult and pediatric patients ages 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation (determined by the Life Technologies Corporation Oncomine Dx Target Test) following surgery, including biopsy, subtotal resection, or gross total resection.

The approval was based on a trial of 331 patients randomly assigned (1:1) to receive Voranigo (40 mg orally once daily) or placebo orally once daily until disease progression or unacceptable toxicity. Results showed a significantly lower risk for progression-free survival with Voranigo (hazard ratio, 0.39). The median time to next intervention was 17.8 months in the placebo arm but was not reached in the Voranigo arm (hazard ratio, 0.26). The most common (≥15 percent) adverse reactions included fatigue, headache, COVID-19 infection, musculoskeletal pain, diarrhea, nausea, and seizure, while the most common grade 3 or 4 laboratory abnormalities (>2 percent) were increased alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase and decreased neutrophils.

“The possibility of delaying radiation therapy and chemotherapy with this drug could be beneficial to select patients with slow growing IDH-mutant gliomas,” Matthias Holdhoff, M.D., Ph.D., from the Johns Hopkins Kimmel Cancer Center, and co-investigator on the 2023 clinical trial, said in a statement. “I believe we are looking at a new standard of care option for these types of tumors.”

Approval of Voranigo was granted to Servier Pharmaceuticals.