Prognia
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🇪🇺EU · EMAAuthorisedATC: L01EX28Conditional Approval

Augtyro(repotrectinib)

Carcinoma, Non-Small-Cell Lung;Cancer

Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG

EMA Authorisation: 13/01/2025

INN: repotrectinib

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)

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.