Therapeutic Response Statement (Sensitivity)

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

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.