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. 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 October 6, 2026.

Contributions

Date	Contributor	Description
2025-06-12	Van Allen lab	The FDA provided regular approval to taletrectinib for the treatment of patients with ROS1 positive non-small cell lung cancer, accelerated approval to telisotuzumab vedotin-tllv for the treatment of patients with non-squamous non-small cell lung cancer with high c-Met expression, and avutometinib in combination with defactinib (Avmapki Fakzynja co-pack) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer.
2025-06-11	Food and Drug Administration	Indication received traditional approval.