Bristol-Myers Squibb Company — Augtyro EMA EPAR public assessment report (EMEA/H/C/006005, 2025)
Bristol-Myers Squibb Company · 2025 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted conditional marketing authorization for Augtyro (repotrectinib) for ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults, and NTRK gene fusion-positive solid tumors in adult and pediatric patients 12 years and older. This decision, supported by the CHMP, followed assessment of data from the TRIDENT-1 and CARE studies. Repotrectinib, an inhibitor of ROS1, ALK, and TRK kinases, demonstrated potent inhibitory activity in vitro and significant tumor growth inhibition in vivo. Clinical trials showed favorable objective response rates and duration of response in both TKI-naïve and pre-treated patients, including intracranial responses. While effective, repotrectinib's safety profile revealed common adverse events, including CNS and GI toxicities, pneumonitis, hepatotoxicity, and vision disorders, leading to dose modifications or discontinuations. Post-marketing commitments include further data collection from ongoing trials to address long-term safety, efficacy, and specific patient populations.
Key findings — cited to the page
| TEAE grade ≥3 (CARE) | 55.3 % | CARE · p.193 |
| Grade ≥3 TEAE rate (TRIDENT-1) | 57.2 % | TRIDENT-1 · p.191 |
| TEAE grade ≥3 (TRIDENT-1) | 57.2 % | TRIDENT-1 · p.193 |
| Higher grade AE rate (ROS1+ NSCLC) | 58.0 % | · p.194 |
| Grade ≥3 TEAE rate (CARE) | 55.3 % | CARE · p.191 |
| Subjects with Grade ≥3 TEAE (Sepsis) | 5.3 % | CARE · p.148 |
| Subjects with Grade ≥3 TEAE (Weight increased) | 15.8 % | CARE · p.147 |
| Subjects with Grade ≥3 TEAE (Hypoxia) | 5.3 % | CARE · p.148 |
| Subjects with Grade ≥ 3 TEAEs | 57.2 % | TRIDENT-1 · p.143 |
| Subjects with Grade 5 TEAE (Brain compression) | 2.6 % | CARE · p.149 |
| Subjects with Grade ≥3 TEAE | 34.7 % | TRIDENT-1 · p.146 |
| Subjects with Grade ≥3 TEAE | 55.3 % | CARE · p.143 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →