The Food and Drug Administration (FDA) has approved Bavencio (avelumab; EMD Serono) injection for the treatment of patients aged ≥12 years with metastatic Merkel cell carcinoma (MCC), including those who have received prior chemotherapy. This marks the first approved treatment for metastatic MCC.

Bavencio is a programmed death ligand-1 (PD-L1) blocking antibody. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. 

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The accelerated approval was based on data from a single-arm study (n=88) in patients with metastatic MCC who were treated with at least one prior chemotherapy regimen. The study assessed the percentage of patients who had complete or partial shrinkage of their tumors (overall response rate) and of those patients with a response, the length of time the tumor was controlled (duration of response). Thirty-three patients experienced complete or partial shrinkage of their tumors, with responses lasting >6 months in 86% of responders, and >12 months in 45% of responders.

Common adverse events include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and peripheral edema.

Bavencio was granted Priority Review and Breakthrough Therapy designation in addition to receiving an Orphan Drug designation. It will be available as 200mg/10mL (20mg/mL) solution in single-dose vials.

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