Rozlytrek FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 25, 2023.
FDA Approved: Yes (First approved August 15, 2019)
Brand name: Rozlytrek
Generic name: entrectinib
Dosage form: Capsules and Oral Pellets
Company: Genentech, Inc.
Treatment for: Solid Tumors, Non-Small Cell Lung Cancer
Rozlytrek (entrectinib) is a selective tyrosine kinase inhibitor for the treatment of patients with ROS1-positive, metastatic non-small cell lung cancer and neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumors.
- Rozlytrek is indicated for the treatment of:
- adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
- adult and pediatric patients older than 1 month of age with solid tumors that:
- have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation,
- are metastatic or where surgical resection is likely to result in severe morbidity, and
- 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.
Development timeline for Rozlytrek
Further information
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