Scemblix (asciminib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig2lbl.pdf. Revised October 2021. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	ABL1 p.T315I, BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Asciminib