A further regulatory milestone has been achieved by Merck KGaA and Pfizer after the US Food and Drug Administration (FDA) designated their potential skin cancer treatment avelumab as a Breakthrough Therapy. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody for treating patients with metastatic Merkel cell carcinoma (MCC), a rare and aggressive form of skin cancer. Approximately 1,500 new cases of MCC are diagnosed in the US every year.

Breakthrough Therapy status is designed to accelerate the development and review of medicines intended to treat a serious condition where early evidence shows a substantial improvement over existing treatments. The designation for avelumab is based on the preliminary evaluation of clinical data from a global Phase 2 study. Results will be presented next year.

If approved, avelumab could potentially become the first immunotherapy to treat metastatic MCC. There is currently no approved treatment that specifically treats this disease. Within the last two months, avelumab has received Orphan Drug and Fast Track designations from the FDA.