Rozlytrek (entrectinib)
- Region
- 🇪🇺 EU
- Active substance
- entrectinib
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Cancer; Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 28 May 2020
- EU approval
- Fri 31 Jul 2020
- Designations
- PRIME, Conditional, Additional monitoring
- Application
- EMEA/H/C/004936
- ATC
- L01EX14
- Official record
- www.ema.europa.eu
Indication
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.