EISAI INC — Lenvima FDA Summary Review (NDA/BLA 206947, 2015)
Eisai Co., Ltd. · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
Lenvima (lenvatinib mesylate) was approved for radioactive iodine-refractory differentiated thyroid cancer based on the SELECT trial, which showed significant improvement in progression-free survival and objective response rate. However, the initial 24 mg daily dose was poorly tolerated, leading to frequent dose reductions and discontinuations. The FDA did not require an advisory committee review due to an acceptable safety profile and appropriate trial design. Lenvima received Orphan Drug Designation. A post-marketing study was mandated to assess the safety and efficacy of lower starting doses (20 mg or 14 mg daily) compared to the initial 24 mg dose, aiming to reduce serious adverse reactions while maintaining comparable response rates.
Key findings — cited to the page
| Grade ≥3 renal impairment (Lenvatinib) | 3 % | · p.14 |
| Grade ≥3 hypocalcemia (Placebo) | 2 % | · p.14 |
| Grade ≥3 arterial thrombolic events (Placebo) | 1 % | · p.14 |
| Grade ≥3 proteinuria (Lenvatinib) | 11 % | · p.14 |
| Grade ≥3 QT prolongation (Lenvatinib) | 2 % | · p.14 |
| Grade ≥3 hypocalcemia (Lenvatinib) | 9 % | · p.14 |
| Grade ≥3 cardiac dysfunction (Lenvatinib) | 2 % | · p.14 |
| Grade ≥3 arterial thrombolic events (Lenvatinib) | 3 % | · p.14 |
| Grade ≥3 ALT elevations (Study 303) | 4 % | Study E7080-G000-303 (SELECT) · p.14 |
| Grade ≥3 AST elevations (Study 303) | 5 % | Study E7080-G000-303 (SELECT) · p.14 |
| Grade ≥3 renal impairment (Placebo) | 1 % | · p.14 |
| Grade 1 to 2 hemorrhage (overall incidence, Lenvatinib) | 35 % | · p.14 |
Source: Eisai 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 →