°®¶¹´«Ã½

• For Print
• December 6, 2019

°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received a notification from Japan’s Ministry of Health, Labour, and Welfare (MHLW) to the effect that the “all-case surveillance” special drug use-results survey condition required for approval of the orally available kinase inhibitor LENVIMA^® (lenvatinib) in treatment of thyroid cancer has been cleared.

In March 2015, the MHLW approved LENVIMA for the treatment of unresectable thyroid cancer with the following condition: “Due to the very limited number of patients included in the Japanese clinical studies, conduct a post-marketing drug use-results survey, covering all patients treated with product, until data from a certain number of patients will be collected, in order to obtain the background information of patients treated with product and collect data on the safety and efficacy of product in the early post-marketing period, and thereby take necessary measures to ensure proper use of product.”

Eisai submitted the safety data for 604 patients and efficacy data for 601 patients of all-case surveillance to the MHLW. Based on these data, MHLW cleared this condition for approval after determining that the all-case surveillance had been appropriately conducted with measures necessary for proper use of the product.

Eisai will continue to promote and provide information on the proper use of LENVIMA and will thereby further contribute to increase the benefits provided to patients and their families.

* In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA.

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[Notes to editors]

1. 1. °®¶¹´«Ã½ LENVIMA^® (lenvatinib)

LENVIMA, discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages population, increased activated cytotoxic T cells population, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.

Currently, LENVIMA has been approved as a treatment for thyroid cancer in more than 55 countries including Japan, the United States, and in Europe; as a treatment for hepatocellular carcinoma in more than 50 countries including Japan, the United States, in Europe, China and in Asia; as well as in combination with everolimus as a treatment for renal cell carcinoma (second-line) in more than 50 countries including the United States, in Europe and Asia. Additionally, it is also approved in the combination treatment of LENVIMA plus KEYTRUDA^® (pembrolizumab) for advanced endometrial carcinoma in the United States, Australia, and Canada. In Europe, the agent was launched under the brand name Kisplyx^® for renal cell carcinoma.

1. 2. °®¶¹´«Ã½ Thyroid Cancer

Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men. The most common types of thyroid cancer, papillary and follicular (including Hürthle cell), are classified as differentiated thyroid cancer and account for approximately 95% of all cases. The remaining cases are classified as either undifferentiated (1-2% of cases) or medullary carcinoma (1-2% of cases). While most differentiated thyroid cancer patients are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy.

1. 3. °®¶¹´«Ã½ the Results of the Special Drug-Use Results Survey

Based on the condition of approval, a special drug-use results survey on LENVIMA was carried out using the all-case centralized method aiming to assess safety and efficacy, as well as to understand the factors affecting safety and efficacy. The enrollment included all patients who started administration in May to November 2015, and 629 patients were collected from 293 institutions in Japan.

The common adverse drug reactions (ADRs) (incidence 10% or higher) regarding safety data for 604 patients were hypertension (76.0%), protein urine (39.4%), palmar-plantar erythrodysesthesia syndrome (36.4%), decreased appetite (23.5%), platelet count decreased (22.4%), fatigue (19.2%), diarrhea (17.1%), blood thyroid stimulating hormone increased (14.9%), stomatitis (10.9%), and blood urine present (10.4%). In addition, the common serious ADRs (incidence 1.0% or higher) were decreased appetite (3.8%), hypertension (2.3%), diarrhea (1.8%), platelet count decreased (1.7%), pneumonia and fistulas (1.2% each), as well as arterial hemorrhage, Impaired healing, and fatigue (1.0% each).

The response rate by histopathological subtypes regarding the efficacy data for 499 patients for which image evaluation was performed was 59.2% for differentiated cancer, 43.8% for undifferentiated cancer, and 45.0% for medullary cancer. The safety and efficacy obtained in this survey is assessed as having no significant differences compared to the data obtained by the time of approval.

1. 4. °®¶¹´«Ã½ the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA.

In addition to ongoing clinical studies evaluating the LENVIMA and KEYTRUDA combination across several different tumor types, the companies will jointly initiate new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program, which will evaluate the combination to support 11 potential indications in six types of cancer. The LEAP clinical program also includes a basket trial targeting six additional cancer types.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

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