Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that v::ROS1 status confers therapeutic sensitivity to Taletrectinib in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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.