The U.S. Food and Drug Aministration has approved a melanoma drug combination to treat advanced stages of the disease that is spreading and cannot be removed by surgery. The have approved Mekinist for use with another drug, Tafinlar.
Melanoma is the most deadly form of skin cancer, which accounts for an estimated 9,480 American deaths last year, the FDA said Friday in a news release. Mekinist is newly approved to be used in combination with the drug Tafinlar. Both drugs were first sanctioned in May 2013 to be used by themselves to battle advanced melanoma, the agency said.
The melanoma drug combination therapy is newly approved for people who have certain mutations in the BRAF V600E and V600K genes, the FDA said. About half of melanoma cases have mutated genes per WebMD.
The combination therapy was clinically evaluated in 162 people. Of those treated 78 percent saw their skin cancer disappear or shrink an average of 10.5 months, the agency said.
The melanoma drug combination has side effects can cause infertility and birth defects, the agency said, in a warning for both men and women of child bearing age.
The most common side effects include, rash, chills, fever, nausea, fatigue, diarrhea, abdominal pain, swelling of the arms and feet. More serious effects include bleeding, heart failure, eye problems, and blood clots.
Both drugs are marketed by GlaxoSmithKline. The company is based in Research Triangle Park, N.C.
“This approval marks another key moment in what continues to be a rapid evolution of the treatment landscape for metastatic melanoma patients. Combining agents that target different mechanisms regulating the growth of cancer cells is one of the promising areas in cancer research,” said Paolo Paoletti, MD, president of oncology at GlaxoSmithKline, in a press statement.
This is the first-ever combination therapy for advanced melanoma.