Avelumab, sold under the brand name Bavencio, is a fully human monoclonal antibody medication for the treatment of Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma. Common side effects include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite and swelling of the limbs (peripheral edema). Avelumab targets the protein programmed death-ligand 1 (PD-L1). It has received orphan drug designation by the European Medicines Agency (EMA) for the treatment of gastric cancer in January 2017. The US Food and Drug Administration (FDA) approved it in March 2017 for Merkel-cell carcinoma. an aggressive type of skin cancer. The EMA approved it in September 2017 for the same indication. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. Avelumab was developed by Merck KGaA and Pfizer. In March 2017, the US Food and Drug Administration (FDA) granted accelerated approval to avelumab for the treatment of adults and children twelve years and older with metastatic Merkel-cell carcinoma (MCC). In May 2017, the FDA approved avelumab for people with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within twelve months of neoadjuvant or adjuvant platinum-containing chemotherapy. In May 2019, the FDA approved avelumab in combination with axitinib for the first-line treatment of people with advanced renal cell carcinoma. In June 2020, the FDA approved avelumab for the maintenance treatment of people with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. No contraindications have been specified. The most common serious adverse reactions to avelumab are immune-mediated adverse reactions (pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and life-threatening infusion reactions.
Michele De Palma, Mario Leonardo Squadrito, Martin Etzrodt
Florian Maria Wurm, Peter Frey