EISAI INC — Lenvima FDA Review (NDA/BLA 206947, 2023)
Eisai Co., Ltd. · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
LENVIMA (lenvatinib) capsules received FDA approval for multiple cancer indications, including Differentiated Thyroid Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma, and Endometrial Carcinoma, both as monotherapy and in combination with other drugs like everolimus and pembrolizumab. The approval package details dosage, administration, and modifications for adverse reactions and organ impairment. Safety data highlights serious adverse events such as cardiac dysfunction, hepatotoxicity, and hemorrhagic events, alongside common reactions and laboratory abnormalities. Efficacy studies demonstrated significant improvements in progression-free survival and objective response rates. The report also covers pharmacokinetic data, packaging, storage, and extensive patient counseling information regarding potential side effects. A Prior Approval Supplement updated suspension preparation and administration instructions for improved clarity and safe use.
Key findings — cited to the page
| Grade 3 hypertension incidence in REFLECT (HCC) | 24% | LENVIMA · p.16 |
| Grade 3 hypertension incidence in SELECT (DTC) | 44% | LENVIMA · p.16 |
| Grade 4 hypertension incidence in SELECT (DTC) | <1% | LENVIMA · p.16 |
| Grade 3 hypertension incidence in Study 205 (RCC) | 13% | LENVIMA · p.16 |
| Grade 3 to 5 hepatic encephalopathy (sorafenib-treated) | 2 % | REFLECT (HCC) · p.17 |
| Grade 3 to 5 hepatic failure (LENVIMA-treated) | 3 % | REFLECT (HCC) · p.17 |
| Grade 3 to 5 hepatic failure (sorafenib-treated) | 3 % | REFLECT (HCC) · p.17 |
| Grade 3 to 5 arterial thromboembolic events | 2 % | LENVIMA clinical trials · p.17 |
| Grade 3 to 5 arterial thromboembolic events | 3 % | LENVIMA clinical trials · p.17 |
| Grade 3 or higher cardiac dysfunction | 3 % | LENVIMA clinical trials · p.17 |
| Grade 3 to 5 hepatic encephalopathy (LENVIMA-treated) | 5 % | REFLECT (HCC) · p.17 |
| Grade 3 to 5 renal failure or impairment | 3 % | SELECT (DTC) · p.18 |
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 →