A newly FDA-approved treatment for patients with advanced or inoperable melanoma who are no longer responding to other drugs is now available to patients at the University of Louisville’s James Graham Brown Cancer Center, a part of KentuckyOne Health. As a site for Keytruda’s research clinical trial, the cancer center is the first in Kentucky to offer the drug now that it is approved.
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.
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.