Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

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

AUGTYRO 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

Bristol-Myers Squibb. Augtyro (repotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf. Revised June 2024. Accessed October 30, 2024. Bristol-Myers Squibb. Augtyro (repotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218213s000lbl.pdf. Revised November 2023. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-11-15	Food and Drug Administration	Indication received traditional approval.