Eisai`s Kisplyx (lenvatinib mesilate) Receives Approval for Europe
LENVIMA has been approved as a treatment for refractory thyroid cancer in over 50 countries.
Eisai Co., Ltd. and Merck Enter Global Strategic Oncology Collaboration for LENVIMA® (lenvatinib mesylate)
Eisai Co., Ltd. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC). The LENVIMA and KEYTRUDA combination therapy is being jointly developed by Eisai and Merck. This is the second Breakthrough Therapy Designation for LENVIMA and the twelfth Breakthrough Therapy Designation granted to KEYTRUDA.
Study 304 is a multicenter, randomized, open-label, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced hepatocellular carcinoma, as a first-line treatment for patients with unresectable hepatocellular carcinoma. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg or 8 mg once a day, depending on baseline body weight (n= 478) or sorafenib 400 mg twice a day (n= 476). Treatment was continued until disease progression or unacceptable toxicity.
This is a summary of the European public assessment report (EPAR) for Kisplyx. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kisplyx.
Singapore: Eisai Co., Ltd. announced that its European regional headquarters Eisai Europe Ltd. has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on anticancer agent lenvatinib mesylate in combination with everolimus. It's for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF) targeted therapy. If approved, lenvatinib will be launched under the brand name Kisplyx for this indication. Read more at: http://www.biospectrumasia.com/biospectrum/news/224059/eisai-receives-positive-chmp-opinion-indication-anticancer-agent
Tokyo-based Eisai is following U.S. approval of kidney cancer drug Lenvima by joining hands with cancer powerhouse Novartis ($NVS) on sales, building on an already solid sales rep force in the country.