Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

This is written in the approval document as:

Tasigna is a kinase inhibitor indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

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.

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
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Nilotinib
Sensitivity (+)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Nilotinib