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.

Keytruda represents a new breed of cancer treatment, Jason Chesney, M.D., Ph.D., 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.

###

About the University of Louisville

The University of Louisville Health Sciences Center is the city’s only academic health center with approximately 1,000 faculty members involved in education, research and clinical care.  The UofL HSC is home to more than 650 medical and dental residents, 3,000 students pursuing degrees in health-related fields within the Schools of Dentistry, Medicine, Nursing and Public Health and Information Sciences, as well as 16 interdisciplinary centers and institutes.  Approximately $140 million in extramural funding enables researchers to uncover the causes of disease and better ways to prevent, treat and cure illness and injury. That research is translated into the clinical setting, where evidence-based medical care for patients is provided by UofL faculty through University of Louisville Physicians, our partnership with KentuckyOne Health, and in affiliations with other health systems and clinics throughout Kentucky and southern Indiana.

About KentuckyOne Health

KentuckyOne Health was formed when two major Kentucky health care organizations came together in early 2012. KentuckyOne Health combines the Jewish and Catholic heritages of the two former systems – Jewish Hospital & St. Mary’s HealthCare and Saint Joseph Health System. In late 2012, the organization formed a partnership with the University of Louisville Hospital | James Graham Brown Cancer Center.  The nonprofit system is committed to improving the health of Kentuckians by integrating medical research, education, technology and health care services wherever patients receive care. KentuckyOne Health has more than 200 locations including hospitals, physician groups, clinics, primary care centers, specialty institutes and home health agencies across the state of Kentucky and southern Indiana.