Ibtrozi (taletrectinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Nuvation Bio Inc. Ibtrozi (taletrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219713s000lbl.pdf. Revised June 2025. Accessed June 12, 2025.

Regulatory approvals

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

Indication	Statements
IBTROZI is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ROS1	Non-Small Cell Lung Cancer	Taletrectinib