TAIHO ONCOLOGY — Lonsurf FDA Review (NDA/BLA 207981, 2025)
Otsuka Holdings Co., Ltd. · 2025 · FDA Review (Drugs@FDA) · company profile →
Report summary
LONSURF (trifluridine and tipiracil) is FDA-approved for metastatic colorectal cancer (mCRC) and metastatic gastric/gastroesophageal junction adenocarcinoma, used alone or with bevacizumab for mCRC. Clinical trials (RECOURSE, SUNLIGHT, TAGS) demonstrate its efficacy and safety, highlighting improved overall and progression-free survival, particularly with bevacizumab combination in refractory mCRC. The SUNLIGHT trial showed significant OS (10.8 vs 7.5 months) and PFS (5.6 vs 2.4 months) benefits. Common adverse reactions include myelosuppression. The drug's pharmacokinetics, use in specific populations, and handling are detailed. The combination therapy maintains a consistent safety profile with no new safety signals, supporting its favorable risk-benefit for regular approval.
Key findings — cited to the page
| Grade 3-4 anemia rate | 5 % | LONSURF in combination with bevacizumab · p.15 |
| All Grades Neutropenia | 67 % | LONSURF (RECOURSE) · p.18 |
| Grade 3-4 anemia rate | 17 % | LONSURF as a single agent · p.15 |
| Grade 3-4 neutropenia rate | 52 % | LONSURF in combination with bevacizumab · p.15 |
| All Grades Anemia | 77 % | LONSURF (RECOURSE) · p.18 |
| Grades 3-4 Anemia | 18 % | LONSURF (RECOURSE) · p.18 |
| Aspartate aminotransferase increased (All Grades) | 34 % | SUNLIGHT · p.20 |
| Grade 3-4 neutropenia rate | 38 % | LONSURF as a single agent · p.15 |
| Grade 3-4 thrombocytopenia rate | 4 % | LONSURF as a single agent · p.15 |
| Grade 3-4 febrile neutropenia rate | 3 % | LONSURF as a single agent · p.15 |
| Grade 3-4 febrile neutropenia rate | 0.4 % | LONSURF in combination with bevacizumab · p.15 |
| Grades 3-4 Neutropenia | 38 % | LONSURF (RECOURSE) · p.18 |
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 →