FDA Approves Bavencio for Merkel Cell Carcinoma

Drug targets the PD-1/PD-L1 pathway; first sanctioned treatment in the United States

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THURSDAY, March 23, 2017 (HealthDay News) -- Bavencio (avelumab) has been approved by the U.S. Food and Drug Administration to treat Merkel cell carcinoma (MCC), the agency said Thursday in a news release.

Bavencio targets the PD-1/PD-L1 pathway, and is sanctioned for patients 12 and older. It is the first MCC treatment approved in the United States. The drug was evaluated in a clinical study of 88 patients with metastatic 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, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, lack of appetite, and peripheral edema. The FDA noted that the more serious side effects were immune-mediated: pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis.

"While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now," Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "The scientific community continues to make advances targeting the body's immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies -- even in rare forms of cancer where treatment options are limited or non-existent."

Approval of Bavencio was granted to EMD Serono (a Germany-based unit of Merck KGaA) and Pfizer.

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