FDA grants accelerated approval to Merck's Keytruda

WHITEHOUSE STATION, N.J. — Merck on Thursday announced that the Food and Drug Administration granted accelerated approval to Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma. An improvement in survival or disease-related symptoms hasn't been established yet, but the tumor response rate and durability response prompted the agency to grant accelerated approval, the company said. 

 

Keytruda is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, according to the company. The drug consists of a humanized monoclonal antibody that increases the ability for the patient's immune system to fight advanced melanoma. 

 

“Keytruda embodies Merck’s unwavering commitment to pursue breakthrough science to help people who are facing the most challenging diseases,” said Kenneth Frazier, chairman and CEO, Merck. “We are grateful to the people with advanced melanoma who participated in our trials, and the scientific and medical community for the shared effort that has led to the accelerated approval of Keytruda.”

 

Merck plans to make the drug available within one week following the FDA's approval.