WHITEHOUSE STATION, N.J.—Merck, which goes by the name MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, its cancer immunotherapy, for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. The drug has received a Breakthrough Therapy designation for advanced melanoma.
Keytruda is a humanized monoclonal antibody that blocks the interaction between programmed death receptor-1 (PD-1) and its ligands, PD-L1 and PD-L2. It is also the first anti-PD-1 therapy to be approved in the United States.
“Keytruda embodies Merck’s unwavering commitment to pursue breakthrough science to help people who are facing the most challenging diseases,” Kenneth C. Frazier, chairman and CEO of Merck, commented in a statement. “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.”
The drug earned the accelerated approval for the unmet medical need in the indication of melanoma and the extent and durability of the patient response seen in trials. The data supporting the advanced approval came from the multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial of patients with unresectable or metastatic melanoma and progression of disease. The major efficacy outcome measures consisted of confirmed overall response rate and response duration. Based on 89 patients who received the recommended 2mg/kg dose, the trial saw an overall response rate of 24 percent, with one complete response and 20 partial responses. At the time of data analysis, 86 percent of patients with objective responses presented with ongoing responses, with durations from 1.4+ to 8.5+ months, including eight patients who witnessed ongoing responses of six months or longer.
“The accelerated FDA approval of Keytruda is a meaningful development for patients with advanced melanoma,” said Dr. Omid Hamid, director of the Melanoma Center at The Angeles Clinic and Research Institute, and a principal investigator for the pembrolizumab melanoma clinical program. “Our new ability to target the PD-1 pathway with Keytruda is a very exciting step in the immunotherapy field.”
Merck is conducting ongoing Phase 2 and Phase 3 clinical studies in patients with advanced melanoma to secure additional confirmatory evidence for the drug, and plans to make Keytruda available within a week of its Sept. 4 approval.
The same day it announced Keytruda’s approval, Merck also noted that the FDA has granted Fast Track designation to Merck’s relebactam, an investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product. Both designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
SOURCE: Merck press release