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EU agency validates application for avelumab for treating metastatic Merkel cell carcinoma

The European Medicines has validated the marketing authorization application for avelumab for the proposed indication of metastatic Merkel cell carcinoma, according to Merck KgaA, Darmstadt, Germany and Pfizer.

Avelumab, an investigational anti-PD-L1 IgG1 monoclonal antibody, could be the first approved indication for metastatic Merkel cell carcinoma (MCC) in the European Union if approved, according to a press release from Pfizer.

“While early-stage [MCC] can be generally managed with surgery, there are significant unmet needs in metastatic disease, where treatment options are severely limited,” Luciano Rossetti, MD, executive vice president, global head of research and development at the biopharma business of Merck KgaA, stated in the release.

The marketing authorization application was based on data from JAVELIN Merkel 200, a multi-center, singly-arm, open-label phase 2 study of 88 patients with metastatic MCC with disease progression after at least one chemotherapy treatment, according to the release.

Avelumab is currently not approved for any indication in any market, according to the release.

Reference: www.pfizer.com