Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that ABL1 p.T315I and BCR::ABL1 status confers therapeutic sensitivity to Asciminib in patients with Chronic Myelogenous Leukemia.
The European Medicines Agency (EMA) has authorized asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) with the T315I variant who are resistant to, intolerant to, or ineligible for ponatinib.
This statement is based on a regulatory approval from the European Medicines Agency:
Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib.