Treats ROS1- positive metastatic non-small cell lung cancer (NSCLC). NDA 218550, held by Genentech Inc. Entrectinib.
As of Nov 14, 2026, NDA 218550 (Rozlytrek), held by Genentech Inc, was first approved by FDA on Oct 20, 2023, with 2 approved supplements and 0 published complete response letters.
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. 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.
| Oct 20, 2023 | Supplement 1New dosage form · Priority review | Approved | |
| Oct 20, 2023 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rozlytrek50MG/PACKET · pellets;oral | Entrectinib | RxReference drug |
| Oct 1, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Oct 20, 2023 | Supplement 1New dosage form · Priority review | Approved | |
| Oct 20, 2023 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
