Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Imatinib in patients with Chronic Myelogenous Leukemia.

The U.S. Food and Drug Administration granted approval to imatinib for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

This statement is based on a regulatory approval from the Food and Drug Administration:

Gleevec is a kinase inhibitor indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

Citation

Novartis Pharmaceuticals Corporation. Gleevec (imatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s062lbl.pdf. Revised August 2022. Accessed October 30, 2024.