Servier — Lonsurf EMA EPAR public assessment report (EMEA/H/C/003897, 2016)
Servier · 2016 · EMA EPAR public assessment report
Report summary
This report summarizes the EMA's assessment of Lonsurf (trifluridine/tipiracil) for metastatic colorectal cancer. It details the regulatory submission, proposed indication, and the drug's composition and mechanism of action. The report also covers the quality aspects of the active substances, trifluridine and tipiracil hydrochloride, including their manufacturing, characterization, and stability.
Key findings — cited to the page
| Marketing Authorisation application submission date | 27 February 2015 | Lonsurf · Europe · p.7 |
| Marketing Authorisation application transfer date | 19 October 2015 | Lonsurf · p.7 |
| Marketing Authorisation approval date | 24 March 2014 | Lonsurf · Japan · p.8 |
| Marketing Authorisation approval date | 22 September 2015 | Lonsurf · United States · p.8 |
| CHMP positive opinion date | 25 February 2016 | Lonsurf · p.8 |
| Colorectal cancer deaths | 215000 | Europe · p.9 |
| 5-year survival rate for stage I CRC | 93 % | · p.9 |
| 5-year survival rate for stage IV CRC | less than 10 % | · p.9 |
| Patients with metastases at initial diagnosis of CRC | approximately 25 % | · p.9 |
| Patients with CRC who will develop metastases | almost 50 % | · p.9 |
| CRC-related 5-year survival rate | 60 % | · p.9 |
| Median survival for untreated mCRC | 6 months | · p.9 |
Source: Servier ↗ · 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 →