FDA approves Voranigo for astrocytoma, oligodendroglioma
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The FDA approved vorasidenib for certain patients with astrocytoma or oligodendroglioma.
The indication applies to use of the agent by adults or children aged 12 years or older with grade 2 disease and a susceptible isocitrate dehydrogenase (IDH) 1 or 2 mutation after surgery.
Vorasidenib (Voranigo, Servier Pharmaceuticals) — an oral IDH1 and IDH2 inhibitor — is the first FDA-approved systemic therapy for this patient population.
The agency based the approval on results of the randomized, multicenter INDIGO trial, which included 331 patients with grade 2 astrocytoma or oligodendroglioma who underwent surgery. All study participants had susceptible IDH1 or IDH2 mutations as determined by the Oncomine Dx Target Test (Life Technologies Corporation/Thermo Fisher Scientific). The trial protocol excluded patients who received prior anti-cancer treatment.
Researchers randomly assigned patients to 40 mg vorasidenib daily or placebo. Treatment continued until disease progression or unacceptable toxicity.
Patients assigned placebo could cross over to vorasidenib after documented radiographic disease progression.
PFS per blinded independent review committee served as the major efficacy outcome measure. Results showed improved PFS with vorasidenib (HR = 0.39; 95% CI, 0.27-0.56).
Time to next intervention — a secondary efficacy outcome measure — also improved with vorasidenib (median, not reached vs. 17.8 months; HR = 0.26; 95% CI, 0.15-0.43).
The most common adverse events reported among at least 15% of patients who received vorasidenib included fatigue, headache, musculoskeletal pain, COVID-19 infection, nausea, diarrhea and seizure.
The most common grade 3 or grade 4 laboratory abnormalities included increased alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase, as well as decreased neutrophils.
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