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Avelumab has been granted accelerated approval by the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy.

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This is the first FDA-approved treatment for metastatic MCC. Avelumab targets the PD-1/PD-L1 pathway; by blocking these interactions, avelumab may help the body's immune system attack cancer cells.


The approval of avelumab was 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 and, for patients with a response, the length of time the tumor was controlled. Of the 88 patients who received avelumab in the trial, 33 percent experienced complete or partial shrinkage of their tumors. The response lasted for more than 6 months in 86 percent of responding patients and more than 12 months in 45 percent of responding patients.