FDA Approves Keytruda for Advanced Melanoma

Editor’s note: Before a drug can be widely prescribed in the U.S., it must first be tested in humans and then approved by the U.S. Food and Drug Administration (FDA). Today, the FDA approved a new drug for treating melanoma. The drug is called Keytruda (pembrolizumab). It is for people with melanoma that is advanced or unresectable (can’t be removed by a surgeon) and is not responding well to other drugs. Keytruda is an “anti-PD-1″ immunotherapy drug that boosts a patient’s own immune system to fight cancer. It works by targeting an immune system molecule called PD-1 that can keep the immune system from attacking tumors. It is now the first anti-PD-1 drug to be approved.

“The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.

“Melanoma, which accounts for approximately 5 percent of all new cancers in the United States, 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 is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.”