Treats ROS1- positive metastatic non-small cell lung cancer (NSCLC). Sold as Rozlytrek. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 3 applications for Entrectinib (sold as Rozlytrek), first approved Aug 15, 2019, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Rozlytrek | Part D | $26.0M | +36% | 260 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Molecularly Stratified Trial for Newly Diagnosed Infant-Type Hemispheric GliomaInfant-Type Hemispheric Glioma · St. Jude Children's Research Hospital | Phase 2 | Not yet recruiting | Nov 4, 2026 |
| Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver MutationsLung Cancer (NSCLC) · Shanghai Zhongshan Hospital | Phase 2 | Not yet recruiting | Sep 21, 2026 |
| Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib ProgressionNon-small Lung Cancer · Innovent Biologics (Suzhou) Co. Ltd. | — | Not yet recruiting | Sep 30, 2025 |
| Study on the Mechanism of Acquired Resistance of EntrectinibROS1 Fusion Positive, Non Small Cell Lung Cancer · Fudan University | — | Recruiting | Sep 30, 2025 |
| Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLCNon-Small Cell Lung Cancer, ROS1 Gene Rearrangement · National Cancer Center, China | — | Not yet recruiting | Nov 19, 2024 |
| Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGSRare Tumour · Peking University Shenzhen Hospital | Phase 2 | Not yet recruiting | Nov 18, 2024 |
| Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS TumorsHigh Grade Glioma, CNS Tumor · St. Jude Children's Research Hospital | Phase 2 | Recruiting | Jul 30, 2024 |
| Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid CancerLocally Advanced Thyroid Gland Carcinoma · West China Hospital | Phase 2 | Recruiting | Jul 1, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 15, 2019 | RozlytrekNDA 212725 · New molecular entity | Genentech Inc | 7 | Marketed |
| Aug 15, 2019 | RozlytrekNDA 212726 · New indication | Genentech Inc | 0 | Marketed |
| Oct 20, 2023 | RozlytrekNDA 218550 · New dosage form | Genentech Inc | 2 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
