TAIHO ONCOLOGY — Lonsurf FDA Review (NDA/BLA 207981, 2021)
Otsuka Holdings Co., Ltd. · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
LONSURF (trifluridine and tipiracil) received FDA approval on January 1, 2020, for metastatic colorectal cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. The approval package details dosage, administration, and safety, including adverse reactions. Pharmacokinetic data covers absorption, distribution, metabolism, and excretion. Efficacy was demonstrated in the RECOURSE and TAGS trials against placebo. The report also addresses the impact of renal and hepatic impairment. A dose adjustment to 20 mg/m2 BID for severe renal impairment was accepted, aiming for comparable drug exposure and safety to patients with normal renal function. Safety analysis showed higher Grade 3+ adverse events in mild/moderate renal impairment at 35 mg/m2, but not in severe renal impairment at the adjusted dose.
Key findings — cited to the page
| Nausea (LONSURF, all grades) | 48 % | RECOURSE · p.15 |
| Diarrhea (LONSURF, all grades) | 32 % | RECOURSE · p.15 |
| Asthenia/fatigue (LONSURF, Grades 3-4) | 7 % | RECOURSE · p.15 |
| Pyrexia (LONSURF, Grades 3-4) | 1 % | RECOURSE · p.15 |
| Nausea (LONSURF, Grades 3-4) | 2 % | RECOURSE · p.15 |
| Grade 3-4 thrombocytopenia | 5 % | LONSURF · p.13 |
| Grade 3-4 febrile neutropenia | 3 % | LONSURF · p.13 |
| Asthenia/fatigue (LONSURF, all grades) | 52 % | RECOURSE · p.15 |
| Grade 3-4 anemia | 18 % | LONSURF · p.13 |
| Pyrexia (LONSURF, all grades) | 19 % | RECOURSE · p.15 |
| Grade 3-4 neutropenia | 38 % | LONSURF · p.13 |
| Diarrhea (LONSURF, Grades 3-4) | 3 % | RECOURSE · p.15 |
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 →