Therapeutic Response Statement (Sensitivity)

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

The U.S. Food and Drug Administration granted approval to entrectinib for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

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

ROZLYTREK is a kinase inhibitor indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Citation

Genentech, Inc. Rozlytrek (entrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212725s011lbl.pdf. Revised January 2024. Accessed October 30, 2024. Genentech, Inc. Rozlytrek (entrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212725s000lbl.pdf. Revised August 2019. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2019-08-15	Food and Drug Administration	Indication received traditional approval.