Augtyro
Augtyro ingredients
| Active ingredient | Strength |
|---|---|
| Repotrectinib | 40 mg/1, 160 mg/1 |
What Augtyro is used for
The FDA lists the approved uses on the official label (below). In the EU, repotrectinib is approved as Augtyro 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)
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Augtyro
- Generic name
- Repotrectinib
- Made by
- E.R. Squibb & Sons, L.L.C.
- Forms
- Capsule
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA218213
- On the US market since
- 2023
Official information
- Augtyro prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Repotrectinib)
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?
Augtyro (Repotrectinib) is a cancer medicine made by E.R. Squibb & Sons, L.L.C., approved by the US FDA.
What are the ingredients of Augtyro?
Augtyro contains Repotrectinib (40 mg/1, 160 mg/1).
Is Augtyro approved in Europe?
The same active substance is approved in the EU as Augtyro.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA