Keytruda (pembrolizumab) was given accelerated approval by the FDA Sept. 4 and is the first approved drug in the United States that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. It is approved for use following other treatments if those treatments fail.
Melanoma accounts for approximately 5 percent of all new cancers in the United States and occurs when cancer cells form in skin cells that make the pigment responsible for color in the skin. According to the National Cancer Institute, an estimated 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.
Keytruda represents a new breed of cancer treatment, Jason Chesney, MD, PhD, deputy director of the Brown Cancer Center, said. “Keytruda is designed to galvanize an immune system attack on tumors by blocking the PD-1 pathway,” he said. “Left unchecked, this pathway allows cancerous cells to pass undetected.
“The drug shows greatest promise as a combination therapy, and this approval, handed down almost two months ahead of schedule, clears the drug for use on patients with advanced skin cancers who have already taken Yervoy (ipilimumab).”
“Adding to the body of research on new, advanced treatments exemplifies the James Graham Brown Cancer Center’s leadership on a regional, and even national, level,” said Mark Milburn, vice president, oncology services, KentuckyOne Health. “The expertise from University of Louisville partnered with the statewide reach of KentuckyOne Health helps citizens all over the Commonwealth and beyond with increased access and new hope to fight cancer.”
The FDA granted Keytruda breakthrough therapy designation because preliminary clinical evidence showed that the drug may offer a substantial improvement over available therapies. It also received priority review and orphan product designation. Priority review is granted to drugs that have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan product designation is given to drugs intended to treat rare diseases.
The FDA action was taken under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. An improvement in survival or disease-related symptoms has not yet been established.
Keytruda is manufactured by Merck and Yervoy is from Bristol-Myers Squibb. For information on Keytruda and its use, contact the James Graham Brown Cancer Center toll free at 1-800-333-2230 or at 502-587-4011.