Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document.

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) ABL1 p.T315I, BCR::ABL1 Chronic Myeloid Leukemia, BCR-ABL1+ Asciminib

Contributions

Date Contributor Description
2025-01-10 Van Allen lab Additional FDA approvals for initial version
2021-10-29 Food and Drug Administration Indication received traditional approval.