Bavencio (avelumab) has been approved by the U.S. Food and Drug Administration to treat a rare but aggressive form of skin cancer called Merkel cell carcinoma (MCC), the agency said Thursday in a news release.
The drug, sanctioned for people 12 and older, is the first MCC treatment approved in the United States. Some 1,600 people in the U.S. are diagnosed annually with the disease. Many cases can be treated surgically, but about half of those diagnosed will have their cancers recur, and the cancer will spread (metastasize) in some 30 percent of cases, the FDA said.
Bavencio targets a protein found on some cancer cells, helping the body’s immune system attack these cells, the FDA said.
The drug was evaluated in a clinical study of 88 people with spreading MCC. About one-third of trial participants given Bavencio had a complete or partial shrinkage of tumors, the agency said.
Bavencio’s common side effects included fatigue, bone and muscle pain, diarrhea, nausea, skin reaction, lack of appetite and swelling of the limbs. More serious side effects occurred when the immune system attacked healthy cells or organs, including the lungs, liver, colon and kidneys, the FDA said.
Approval of Bavencio was granted to EMD Serono, a Germany-based unit of Merck & Co.
The FDA has more about this approval.