FDA Approves First Treatment for Form of Skin Cancer

The administration has accelerated approval for a drug used to treat metastatic Merkel cell carcinoma (MCC).

The Food and Drug Administration announced it has granted accelerated approval to Bavencio for the treatment of patients with metastatic Merkel cell carcinoma (MCC).  This is the first FDA-approved treatment for the rare and aggressive form of skin cancer.

"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," said Dr. Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research and director of FDA's Oncology Center of Excellence. "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."

Approximately 1,600 people in the United States are diagnosed with MCC every year, according to the report. Half of all patients experience recurrence, and more than 30 percent will eventually develop metastatic disease.

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