Eisai Co., Ltd. — Kisplyx EMA EPAR public assessment report (EMEA/H/C/004224, 2016)
Eisai Co., Ltd. · 2016 · EMA EPAR public assessment report · company profile →
Report summary
The EMA assessed Kisplyx (lenvatinib) for advanced renal cell carcinoma (RCC) in combination with everolimus, following one prior VEGF-targeted therapy. Eisai Europe Ltd. received accelerated assessment due to unmet medical need. The report details the manufacturing, quality control, and stability of lenvatinib mesilate and Kisplyx capsules. Preclinical studies demonstrated lenvatinib's kinase inhibition, anti-angiogenic effects, and significant tumor growth inhibition in xenograft models, both alone and with everolimus. Pharmacokinetic profiles, metabolism, and safety pharmacology were evaluated in animals, showing dose-dependent toxicities and teratogenicity. Lenvatinib is a substrate for P-gp and BCRP and inhibits other transporters. Drug interaction studies with various compounds, including everolimus, were conducted, supporting the rationale for their synergistic combination in RCC. Environmental risk was deemed low.
Key findings — cited to the page
| Kidney cancer percentage of all cancers worldwide | 3 % | Global · p.9 |
| Clear cell RCC percentage of sporadic RCC in adults | 70% –85% | · p.9 |
| Proposed daily dose of everolimus | 5 mg | Kisplyx · p.12 |
| Lenvima approval date for differentiated thyroid cancer | 28 May 2015 | Lenvima · EU · p.9 |
| 5-year prevalence of RCC in EU-28 (plus Iceland and Norway) | 229,465 cases | EU-28, Iceland, Norway · p.9 |
| Marketing authorization application submission date | 11 January 2016 | Kisplyx · Europe · p.7 |
| Approved indication for Kisplyx | Kisplyx is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one vascular endothelial growth factor (VEGF)-targeted prior therapy | Kisplyx · p.12 |
| Eligibility to centralised procedure agreed date | 21 May 2015 | Kisplyx · Europe · p.7 |
| Proposed daily dose of lenvatinib | 18 mg | Kisplyx · p.12 |
| CHMP positive opinion date | 21 July 2016 | Kisplyx · Europe · p.8 |
| Acceptability of accelerated review agreed date | 19 November 2015 | Kisplyx · Europe · p.7 |
| Papillary RCC percentage of non clear RCC | 7% –15% | · p.9 |
Source: Eisai Co., Ltd. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →