VORANIGO is the first and only FDA-approved targeted treatment in Grade 2 IDH-mutant glioma VORANIGO demonstrated significant improvement in progression free survival with a favorable safety profile in a pivotal Phase 3 study of patients with Grade 2 IDH-mutant glioma VORANIGO is the sixth approval for Servier in the field of IDH-mutant targeted therapies BOSTON , Aug. 6, 2024 /PRNewswire/ -- Servier today announced that the U.S.
Food and Drug Administration (FDA) has approved VORANIGO®, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection. VORANIGO is available and offers glioma patients the ability to actively manage their disease with the convenience of a once-daily pill. Gliomas are types of brain cancer that can hinder normal brain function and cause a variety of symptoms.
Diffuse gliomas with IDH mutations represent the most common malignant primary brain tumors diagnosed in adults younger than 50 years of age. They are not curable with current therapies and without treatment they continue to grow and infiltrate normal brain tissue. 1, 2, 3 "Today's approval of VORANIGO is an enormous leap forward in cancer care, and a defining moment for people living with Grade 2 IDH-mutant glioma," said Arj.