Regulatory approval
Published by the European Medicines Agency.
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 is written in the approval document as:
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.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.