FDA Approves Bavencio (avelumab) for Rare Skin Cancer

James Radke

The FDA has granted accelerated approval to Bavencio (avelumab) for treating metastatic Merkel cell carcinoma (MCC), a rare skin cancer. This is the first FDA-approved treatment for this condition. 

What is Merkel Cell Carcinoma?

Merkel cell carcinoma (MCC) is a rare disease in which malignant cells form in the skin. Merkel cells are found in the top layer of the skin. MCC most often begins in areas of skin exposed to the sun, especially the head and neck, as well as the arms, legs, and trunk.
Approximately, 1600 people in the US are diagnosed with MCC each year. While the majority of patients present with localized tumors that can be treated with surgical resection, approximately half of all patients will experience recurrence, and more than 30% will eventually develop metastatic disease. In patients with metastatic MCC, the cancer has spread beyond the skin into other parts of the body. 

FDA's Assessment

In a news release, Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products at the FDA said, “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.”
Bavencio targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). By blocking these interactions, Bavencio may help the body’s immune system attack cancer cells.
Bavencio received an Accelerated Approval based on data from a single-arm trial of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen. The trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and, for patients with a response, the length of time the tumor was controlled (duration of response).
Of the 88 patients who received Bavencio in the trial, 33% experienced complete or partial shrinkage of their tumors. The response lasted for more than six months in 86% of responding patients and more than 12 months in 45% of responding patients.
Common side effects of Bavencio include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite and swelling of the limbs (peripheral edema).
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