EMA Clears Avelumab MAA for Rare Skin Cancer
The European Medicines Agency has accepted the marketing authorization application for avelumab for the proposed indication of metastatic Merkel cell carcinoma.
The application is based on Phase II data from a study that has shown meaningful tumor responses in patients with metastatic disease that progressed after prior chemotherapy.
Validation of the MAA confirms that submission is complete and starts the EMA’s centralized review process.
Merkel cell carcinoma is a rare skin cancer that impacts around 2,500 Europeans annually.