Augtyro
What Augtyro is used for
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)
Approved use, as published by the European Medicines Agency.
What the labels mean
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Augtyro
- Active substance
- repotrectinib
- Disease area
- Carcinoma, Non-Small-Cell Lung; Cancer
- Medicine group
- Antineoplastic agents
- ATC code
- L01EX28
- Marketing authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Authorised in the EU since
- 2025
Official information
In the USA
Same active substance: Augtyro
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Augtyro used for?
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)
What is the active substance in Augtyro?
Augtyro contains repotrectinib.
Who makes Augtyro?
The EU marketing authorisation holder is Bristol-Myers Squibb Pharma EEIG.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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