Validation of the MAA confirms that submission is complete and starts the EMA’s centralized review process.
The application is based on phase II data from the Javelin Merkel 200 study showing meaningful tumor responses in patients with metastatic disease that progressed after prior chemotherapy.
Merck executive vice president, global head of research & development at the biopharma business Luciano Rossetti said: "While early-stage Merkel cell carcinoma can be generally managed with surgery, there are significant unmet needs in metastatic disease, where treatment options are severely limited.
"We are pleased that the EMA is initiating its review of avelumab, as this means we are one step closer to bringing a much-needed new treatment option to European patients."
The European Commission granted avelumab orphan drug designation for MCC. Its development involves nearly 30 clinical programs and over 2,900 patients assessed across more than 15 different tumor types.
Avelumab, which is not approved for any indication in any market, is believed to have a dual mechanism of action which may allow the immune system to identify and attack cancer cells.
Image: Merck executive vice president, global head of research & development at the biopharma business Luciano Rossetti. Photo: courtesy of Merck KGaA, Darmstadt, Germany.