Therapeutic Response Statement (Sensitivity) Deprecated

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

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. Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215358s001lbl.pdf. Revised October 2022. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2026-09-28	Van Allen lab	Deprecated statements when consolidating CML and CML Ph+ disease codings.
2025-06-26	Van Allen lab	Resolving statements mapped to incorrect propositions
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2022-10-12	Food and Drug Administration	Indication received traditional approval.