Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ABL1 p.T315I status confers therapeutic sensitivity to Ponatinib in patients with Chronic Myelogenous Leukemia.
The U.S. Food and Drug Administration granted approval to ponatinib for the treatment of adult patients with T315I-positive chronic myeloid leukemia (CML) in chronic phase, accelerated phase, or blast phase. The product label states the following limitations of use: ponatinib is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
This statement is based on a regulatory approval from the Food and Drug Administration:
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase). Limitations of Use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.