FDA Approves Voranigo for Grade 2 Brain Tumors

The U.S. Food and Drug Administration (FDA) has granted approval for Voranigo (vorasidenib), a medication designed to treat grade 2 astrocytoma or oligodendroglioma in patients with a specific genetic mutation. This decision affects both adult and pediatric patients aged 12 years and older who have a susceptible mutation in the isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) genes. The identification of these mutations is determined through the Life Technologies Corporation Oncomine Dx Target Test.

The approval was based on a clinical trial involving 331 patients, who were randomly assigned in a 1:1 ratio to receive either Voranigo or a placebo. The medication was administered as a 40 mg oral dose once daily, continuing until either disease progression or unacceptable toxicity was observed. The trial yielded significant results, demonstrating a lower risk of disease progression in patients treated with Voranigo. Specifically, the hazard ratio for progression-free survival was 0.39, indicating a substantial benefit in delaying disease advancement. Additionally, the median time to the next medical intervention was 17.8 months for those receiving the placebo, while it was not reached for patients in the Voranigo group, with a hazard ratio of 0.26.

Common adverse reactions observed in 15% or more of participants included fatigue, headache, COVID-19 infection, musculoskeletal pain, diarrhea, nausea, and seizures. The most frequently reported grade 3 or 4 laboratory abnormalities, occurring in more than 2% of patients, were increased levels of alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase, as well as decreased neutrophil counts.

Dr. Matthias Holdhoff, M.D., Ph.D., from the Johns Hopkins Kimmel Cancer Center and a co-investigator in the clinical trial, highlighted the potential benefits of Voranigo. He noted that delaying the need for radiation therapy and chemotherapy could be advantageous for patients with slow-growing IDH-mutant gliomas. Dr. Holdhoff expressed optimism that Voranigo could represent a new standard of care for these types of tumors.

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