FDA Approves First Treatment for Rare Skin Cancer, Merkel Cell Carcinoma

The first treatment for Merkel cell carcinoma, a rare form of skin cancer, has been approved to treat adults and pediatric patients 12 years or older. The drug is also under consideration through Priority Review for treatment of patients with urothelial carcinoma.

The first treatment for Merkel cell carcinoma (MCC), a rare form of skin cancer, has been approved to treat adults and pediatric patients 12 years or older. The FDA granted an accelerated approval of EMD Serono’s Bavencio (avelumab) back in November 2016. The drug is also under consideration through Priority Review for treatment of patients with urothelial carcinoma.

While skin cancer is a common cancer, MCC is rare, with only 1600 people diagnosed in the United States every year.

“The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer,” Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence, said in a statement. “These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent.”

Bavencio was approved to treat patients with metastatic MCC, including those who have not received prior chemotherapy treatment. Bavencio is a PD-1/PD-L1 inhibitor that could help the body’s immune system attack cancer cells.

The drug was approved based on data from the phase 2 JAVELIN Merkel 200 study, a single-arm trial of 88 patients with metastatic MCC. The participants had been treated previously with chemotherapy, and the trial found that 33% of patients experience complete or partial shrinkage of their tumors. Slightly less than half (45%) of responding patients had a response that lasted more than 12 months, while 86% had a response that lasted more than 6 months.

Common side effects of Bavencio include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and swelling of the limbs.