Scemblix (asciminib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

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 previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).	2
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation.	1
SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Asciminib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Asciminib
Sensitivity (+)	ABL1 p.T315I, BCR::ABL1	Chronic Myelogenous Leukemia	Asciminib
Sensitivity (+)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Asciminib