Rozlytrek (entrectinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	v::ROS1	Non-Small Cell Lung Cancer	Entrectinib