Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that 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 previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

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 previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

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.