Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that IDH1 p.R132H status confers therapeutic sensitivity to Vorasidenib in patients with Oligodendroglioma.
The European Medicines Agency (EMA) has authorized vorasidenib as a monotherapy for the treatment of adult and adolescent patients aged 12 years and older with predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation. Eligible patients must be weighing at least 40 kg and who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.
This statement is based on a regulatory approval from the European Medicines Agency:
Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.