TAIHO ONCOLOGY — Lonsurf FDA Summary Review (NDA/BLA 207981, 2015)
Otsuka Holdings Co., Ltd. · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Lonsurf (trifluridine/tipiracil) for metastatic colorectal cancer based on its demonstrated efficacy in the RECOURSE trial, which showed improved overall and progression-free survival compared to placebo. While myelosuppression was a primary safety concern, the drug's overall risk-benefit profile was considered acceptable for approval.
Key findings — cited to the page
| Incidence of Grade 3-4 decreased appetite | 4 % | trifluridine/tipiracil · p.12 |
| Incidence of Grade 3-4 thrombocytopenia | 5 % | trifluridine/tipiracil · p.13 |
| Grade 3-4 anemia incidence | 18 % | trifluridine/tipiracil · p.4 |
| Incidence of Grade 3-4 asthenia/fatigue | 7 % | trifluridine/tipiracil · p.12 |
| Incidence of Grade 3-4 neutropenia | 38 % | trifluridine/tipiracil · p.13 |
| Incidence of Grade 3-4 anemia | 18 % | trifluridine/tipiracil · p.13 |
| Grade 3-4 neutropenia incidence | 38 % | trifluridine/tipiracil · p.4 |
| Incidence of Grade 3-4 thrombocytopenia | 5 % | · p.16 |
| Incidence of Grade 3-4 anemia | 18 % | · p.16 |
| Grade 3-4 thrombocytopenia incidence | 5 % | trifluridine/tipiracil · p.4 |
| Incidence of Grade 3-4 diarrhea | 3 % | trifluridine/tipiracil · p.12 |
| Incidence of Grade 3-4 asthenia/fatigue | 7 % | · p.16 |
Source: Otsuka Holdings Co., Ltd. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →