Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.

This is written in the approval document as:

Tasigna is a kinase inhibitor indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.

Citation

Novartis Pharmaceuticals Corporation. Tasigna (nilotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf. Revised February 2024. Accessed October 30, 2024.

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Therapeutic response

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

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