EMA — authorised 13 January 2025
- Application: EMEA/H/C/006005
- Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
- Local brand name: Augtyro
- 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)
- Pathway: conditional
- Status: approved
On 13 January 2025, the European Medicines Agency (EMA) granted marketing authorisation for Augtyro, a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro is also indicated for the treatment of paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion. This authorisation was granted under the conditional approval pathway.