Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) granted approval to taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. The package insert instructs to select patients based on the presence of ROS1 rearrangements in tumor specimen(s).

This is written in the approval document as:

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).

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.

Therapeutic response

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

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