Augtyro (repotrectinib)
- Region
- 🇪🇺 EU
- Active substance
- repotrectinib
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung; Cancer
- CHMP opinion
- Thu 14 Nov 2024
- EU approval
- Mon 13 Jan 2025
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/006005
- ATC
- L01EX28
- Official record
- www.ema.europa.eu
Indication
Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)
Regulatory milestones
No milestones recorded in the last year.
Follow Augtyro
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.