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/2023/212725Orig1s009Correctedlbl.pdf. Revised October 2023. 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 and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	v::NTRK1	Any solid tumor	Entrectinib
FDA (1)	v::NTRK2	Any solid tumor	Entrectinib
FDA (1)	v::NTRK3	Any solid tumor	Entrectinib