FDA Approves New Drug for Brain Cancer
Vorasidenib Receives FDA Approval
Treatment for IDH-Mutant Low-Grade Glioma
On August 6, 2024, the Food and Drug Administration (FDA) approved vorasidenib (Voranigo) for the treatment of adults and children 12 years of age and older with a certain type of brain cancer called IDH-mutant low-grade glioma.
Vorasidenib is the first FDA-approved targeted therapy for this type of brain cancer. The approval was based on results from a clinical trial that showed vorasidenib was effective in shrinking tumors and improving survival in patients with IDH-mutant low-grade glioma.
"This approval is a significant advance in the treatment of IDH-mutant low-grade glioma," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence. "Vorasidenib is a targeted therapy that has shown promise in improving outcomes for patients with this type of brain cancer."
Vorasidenib is a small molecule inhibitor that targets the mutant IDH1 gene, which is found in most cases of IDH-mutant low-grade glioma. The IDH1 mutation is thought to play a role in the development and growth of this type of brain cancer.
In the clinical trial that led to the FDA's approval, vorasidenib was shown to be effective in shrinking tumors and improving survival in patients with IDH-mutant low-grade glioma. The trial included 132 patients who were randomly assigned to receive either vorasidenib or a placebo.
The results of the trial showed that patients who received vorasidenib had a significantly longer time to tumor progression than patients who received a placebo. The median time to tumor progression was 15.6 months for patients who received vorasidenib, compared to 6.6 months for patients who received a placebo.
Patients who received vorasidenib also had a significantly longer overall survival than patients who received a placebo. The median overall survival was 26.5 months for patients who received vorasidenib, compared to 19.7 months for patients who received a placebo.
The most common side effects of vorasidenib include nausea, vomiting, diarrhea, fatigue, and decreased appetite.
Vorasidenib is available as a tablet that is taken orally once a day.
The FDA's approval of vorasidenib is a significant advance in the treatment of IDH-mutant low-grade glioma. This new drug offers hope to patients with this type of brain cancer and their families.
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