Eisai and Merck have 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.
The Breakthrough Therapy Designation is an 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 RCC cohort in Study 111, a multicenter, open-label phase 1b/2 clinical study being carried out in the U.S. and the European Union (EU) to evaluate the efficacy and safety of LENVIMA in combination with KEYTRUDA in subjects with selected solid tumors.
"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,” Dr. Takashi Owa, Vice President, Chief Medicine Creation Officer, Oncology Business Group, Eisai, said. “As a human health care company dedicated to giving our first thought to patients, we are committed to working closely with Merck and the FDA to expedite this clinical program with the hope that we may offer another important option for patients in need."