Merck KGaA and Pfizer given Fast Track status for avelumab

Merck KGaA and Pfizer have been given Fast Track status in the US to help speed up the development of their investigational immunotherapy avelumab.

It is designed to target an aggressive form of skin cancer called metastatic Merkel cell carcinoma by acting as a checkpoint inhibitor to block the interaction of PD-L1 with its receptor PD-1.

This form of skin cancer results in cancer cells forming in the top layer of the skin in close vicinity to nerve endings and usually manifests itself in areas of the skin that are frequently exposed to the sun, such as arms, legs and neck.

Dr Luciano Rossetti, head of global research and development for Merck's biopharmaceutical business, Merck Serono, said the firm is "pleased that the [US Food and Drug Administration] continues to acknowledge the current high unmet needs for patients with metastatic Merkel cell carcinoma".

The Fast Track designation is used to develop drugs that will tackle an urgent unmet medical need. Once a drug has been given Fast Track status, the manufacturer will be in frequent contact with the FSA to ensure the drug is granted approval as soon as possible.