Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that ABL1 p.T315I, BCR::ABL1 status confers therapeutic sensitivity to Asciminib in patients with Chronic Myelogenous Leukemia.

The U.S. Food and Drug Administration granted approval to asciminib for the treatment of adult patients with philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation.

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

SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation.

Citation

Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf. Revised October 2024. Accessed January 10, 2025.