EMA Accepts Merck's Pembrolizumab MAA For Review
Merck reported that its Marketing Authorization Application (MAA) for its investigational anti PD-1 antibody pembrolizumab has been accepted for review by the European Medicines Agency (EMA). If approved, the drug could possibly be the first anti PD-1 therapy in the EU.
Pembrolizumab (MK-3475) is a humanized, selective, monoclonal anti PD-1 antibody that aims to reactivate anti-tumor immunity in patients with cancer. The drug blocks dual ligands of the PD-q pathway by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1 and PD-L2. Pembrolizumab is under development and investigation in over 30 types of cancer, both as monotherapy and in combination with other drugs. Merck’s current development program for pembrolizumab is expected to grow to more than 24 clinical trials involving approximately 6,000 patients at almost 300 trial sites across the world.
“With the five-year survival rate for patients with advanced melanoma at less than 20 percent, there remains a need to offer patients additional options. We are pleased to have regulatory applications under review in the United States and Europe as we work toward bringing pembrolizumab to patients around the world,” said Dr. Roy Baynes, SVP of clinical development at Merck Research Laboratories.
Melanoma claimed an estimated 22,200 lives in EU in 2012. The disease is the most serious form of skin cancer and is the 19th leading cause of cancer in Europe. In 2012, approximately 232,000 new cases of melanoma were diagnosed around the world.
The drug has received Breakthrough Therapy designation in advanced melanoma. If approved, pembrolizumab could also become the first anti PD-1 therapy in the U.S, as well as in the EU.
The company’s Biologics License Application (BLA) for pembrolizumab is under priority review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced melanoma previously-treated with ipilimumab with a PDUFA date of October 28, 2014.