Merck and Pfizer’s investigational immunotherapy avelumab has been granted Fast Track designation in the US in a move designed to accelerate its development for a rare and aggressive skin cancer called metastatic Merkel cell carcinoma.

The disease, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, is characterised by the formation of cancer cells in the top layer of the skin, close to nerve endings. Current treatment options include surgery, radiation and chemotherapy, but the firms say there remains a serious, unmet medical need for patients with the disease.

Avelumab is a checkpoint inhibitor that blocks the interaction of PD-L1 with its receptor PD-1, potentially restoring effective anti-tumour T-cell responses and thereby to inhibiting cancer growth.


The drug, which is being assessed my Pfizer and Merck under a deal allowing up to 20 immuno-oncology clinical development programmes, has also been awarded orphan drug status by the US Food and Drug Administration in the MCC indication.

More than 1,000 patients have already been treated with the drug in clinical trials across various tumour types, including breast cancer, gastric/gastroesophageal cancer, head and neck cancer, MCC, mesothelioma, melanoma, lung cancer, ovarian cancer, renal cell carcinoma and urothelial cancer.