Eisai and Merck & Co., Inc., Kenilworth, N.J., USA. Receive Breakthrough Therapy Designation from U.S. FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab) as Combination Therapy for Advanced and/or Metastatic Renal Cell Carcinoma

Eisai Co., Ltd. & Merck & Co., Inc. Kenilworth, N.J., USA have announced that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (generic name: lenvatinib mesylate) in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (generic name: pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma.

The LENVIMA and KEYTRUDA combination therapy is being jointly developed by Eisai and MSD. This is the second Breakthrough Therapy Designation for LENVIMA and the twelfth Breakthrough Therapy Designation granted to KEYTRUDA.

The Breakthrough Therapy Designation is a U.S. FDA program intended to expedite development and review of drugs for serious or life-threatening conditions. In order to qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. The benefits of this Breakthrough Therapy Designation include more intensive guidance on an efficient drug development program, access to a regulatory liaison to help accelerate review time, and eligibility for rolling review as well as priority review.

This Breakthrough Therapy Designation was based on the results of the renal cell carcinoma cohort in Study 111,1 a multicenter, open-label Phase Ib/II clinical study being carried out in the United States and the European Union to evaluate the efficacy and safety of LENVIMA in combination with KEYTRUDA in subjects with selected solid tumors.

Dr. Takashi Owa, Chief Medicine Creation Officer, Oncology Business Group, Eisai Co., Ltd., commented: “We are encouraged that the FDA has recognized the potential of LENVIMA plus KEYTRUDA for patients with advanced and/or metastatic renal cell carcinoma with the Breakthrough Therapy Designation. As a human health care company dedicated to giving our first thought to patients, we are committed to working closely with MSD and the FDA to expedite this clinical program with the hope that we may offer another important option for patients in need.”

“The FDA’s Breakthrough Therapy Designation for the LENVIMA and KEYTRUDA combination in advanced and/or metastatic renal cell carcinoma provides us with the opportunity to accelerate our effort to bring an important potential treatment option to these patients,” said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories. “We remain committed to understanding the full potential of KEYTRUDA across cancers and treatment settings, and our collaboration with Eisai is one of the many ways we are executing on this commitment to helping more patients.”

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