Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	v::ROS1	Non-Small Cell Lung Cancer	Entrectinib

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.