Nordic B V — Teysuno EMA EPAR public assessment report (EMEA/H/C/001242, 2011)
Nordic B V · 2011 · EMA EPAR public assessment report
Report summary
This EMA report details the 2010 regulatory assessment of Teysuno (tegafur/gimeracil/oteracil) for advanced gastric cancer, initially an orphan drug. The application sought marketing authorization for Teysuno plus cisplatin, building on existing Asian approvals. The report covers quality aspects, non-clinical pharmacology, pharmacokinetics, and toxicology, including reproductive and developmental toxicity concerns due to tegafur. It highlights oteracil's role in mitigating toxicity and optimizing the component ratio. Pharmacokinetic properties of Teysuno's components are detailed. The report also presents results from the S-1301/FLAGS Phase III study, comparing Teysuno plus cisplatin to 5-FU plus cisplatin, focusing on survival and response rates. Finally, it outlines Teysuno's safety profile, adverse event rates, and the risk management plan.
Key findings — cited to the page
| Incidence of Grade 3-4 diarrhoea (S-1 for gastric cancer) | 2.0 % | Study 1011 · Japan · p.60 |
| Incidence of Grade ≥3 hematologic toxicities (S-1 for gastric cancer, CrCl <30 ml/min) | 45.0 % | · p.60 |
| Incidence of Grade ≥3 AEs (S-1 for gastric cancer, CrCl >80 ml/min) | 13.8 % | · p.61 |
| Incidence of all grades hematologic toxicities (S-1 for gastric cancer, CrCl <30 ml/min) | 70.0 % | · p.60 |
| Incidence of Grade ≥3 AEs (S-1 for gastric cancer) | 25.0 % | Study 1011 · Japan · p.60 |
| Incidence of all grades AEs (S-1 for gastric cancer, CrCl >80 ml/min) | 47.6 % | · p.61 |
| Marketing Authorisation in Singapore | 13 July 2009 | Teysuno · Singapore · p.6 |
| Marketing Authorisation in China | 9 January 2009 | Teysuno · China · p.6 |
| 5-year survival proportion for metastatic gastric cancer | 7%-27% | · p.7 |
| Prevalence of gastric cancer (orphan designation) | 3 per 10,000 EU populations | Teysuno · EU · p.5 |
| Marketing Authorisation in South Korea | 29 July 2003 | Teysuno · South Korea · p.6 |
| Orphan medicinal product designation date | 20 December 2007 | Teysuno · EU · p.5 |
Source: Nordic B V ↗ · 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 →