European Commission Grants Marketing Authorisation for Kisplyx® ▼ (Lenvatinib) in Combination with Everolimus in Advanced Renal Cell Carcinoma

HATFIELD, England, September 15, 2016 /PRNewswire/ --


Marketing authorisation for the use of lenvatinib in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one

prior vascular endothelial growth factor (VEGF)-targeted therapy  

The European Commission (EC) has issued a marketing authorisation for Kisplyx(R)  (lenvatinib) in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. Lenvatinib was granted an accelerated assessment by the European Medicines Agency in October 2015.

"This is a positive milestone in the clinical management of advanced renal cell carcinoma in Europe. Lenvatinib in combination with everolimus is the first and only proven regimen in Europe to combine treatments that inhibit receptor tyrosine kinases and mammalian target of rapamycin, key targets of advanced renal cell carcinoma treatment," comments Hilary Glen, Medical Oncologist, Beatson West of Scotland Cancer Centre, Glasgow, UK.

Marketing authorisation follows the evaluation of results from a pivotal Phase II trial, which showed that lenvatinib plus everolimus significantly extended progression-free survival in patients with unresectable advanced renal cell carcinoma versus everolimus alone.[1] The pivotal Phase II study evaluated 153 people living with advanced renal cell carcinoma who had progressed after one previous VEGF therapy.[1]  Patients experienced a median progression-free survival of 14.6 months when treated with lenvatinib in combination with everolimus (n=51), compared with 5.5 months for those who received everolimus alone (n=50) (HR 0.40; 95% CI: 0.24-0.67; p=0.0005). [1]Updated median overall survival in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus group (HR 0.59; 95% CI 0.36 - 0.97).[1]

For lenvatinib in combination with everolimus, the most common any-grade treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhoea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhoea, fatigue and hypertension.[1]

Exploratory subgroup analyses of the Phase II study presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2016, found that progression-free survival benefit was maintained across all subgroups regardless of high risk poor prognosis renal cancer subgroups (MSKCC risk, baseline tumour size, metastasis site).[2]

Renal cell carcinoma (RCC) represents 2-3% of all cancer diagnoses[3] and originates in the lining of the tubules, the very small tubes in the kidney that are involved in the blood filtration process to remove waste products.[4]

"This marketing authorisation underscores Eisai's ongoing commitment to delivering and developing advances in the fight against cancer. We remain committed to exploring the potential of lenvatinib for people with cancer, their family and carers," comments Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA.

Lenvatinib selectively inhibits the kinase activities of several different receptors including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), RET, KIT and platelet-derived growth factor receptors (PDGFR).[5] Recent additional data in human RCC xenograft models indicate that lenvatinib in combination with everolimus causes significant antitumour effects through the potent antiangiogenic activity of lenvatinib and direct antitumour activity of everolimus.[6]

In May 2016, the US Food and Drug Administration (FDA) approved lenvatinib in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma who were previously treated with an antiangiogenic therapy.

Lenvatinib has been approved for the treatment of radioiodine refractory thyroid cancer in the United States, Europe, Russia, Switzerland, Australia, Canada, Israel, Singapore, Japan, South Korea and Brazil. Lenvatinib was granted Orphan Drug Designation in Japan for thyroid cancer, in the United States for treatment of follicular, medullary, anaplastic, and locally advanced papillary thyroid cancer and in Europe for follicular and papillary thyroid cancer.

The development of lenvatinib underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of oncology and to address the unmet medical needs of patients and their families.

Notes to Editors  

About Everolimus  

Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor. mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers.[7]

About Eisai Co., Ltd.  

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high-unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit


1. Kisplyx SMPC, August 2016.

2. Hutson T, et al. Subgroup analyses from the phase 2 trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic renal cell carcinoma (mRCC). American Society for Clinical Oncology annual meeting 2016; Poster # 175

3. Ljungberg et al. Guidelines on Renal Cell Carcinoma. Available at: Accessed: September 2016

4. National Cancer Institute at the National Institute of Health. General Information about Renal Cell Cancer. Available at: Accessed: September 2016

5. Matsui J, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008;122:664-671

6. Adachi Y, et al. Lenvatinib in Combination with Everolimus Demonstrated Enhanced Antiangiogenesis and Antitumor Activity in Human RCC Xenograft Models. AACR 2016; #3264

7. SPC Afinitor. Available at: Accessed: September 2016

Date of preparation: September 2016 
Job code: Lenvatinib-EU0063 



CONTACT: Media Enquiries: Eisai: Cressida Robson / Ben Speller,+44-7908-314-155 / +44-7947-231-513, / Tonic Life Communications: Alex Davies / CallumHaire, +44-7716-324-722 / +44-7867-429-637, /

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