Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted accelerated approval to entrectinib 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. Entrectinib's package insert further states that this indication is approved under accelerated approval based on tumor response rate and durability of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::NTRK1	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK2	Any solid tumor	Entrectinib
Sensitivity (+)	v::NTRK3	Any solid tumor	Entrectinib