Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that IDH2 p.R172S status confers therapeutic sensitivity to Vorasidenib in patients with Oligodendroglioma.
The U.S. Food and Drug Administration (FDA) has granted approval to vorasidenib 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.
This statement is based on a regulatory approval from the Food and Drug Administration:
VORANIGO is 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.