The FDA has granted accelerated approval to Bavencio (avelumab) for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, which is a rare, aggressive form of skin cancer.
Bavencio targets the PD-1/PD-L1 pathway — proteins found on the body’s immune cells and some cancer cells. By blocking these interactions, the drug may help the body’s immune system attack cancer cells.
Accelerated approval of the drug was granted based on data from a single-arm trial of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen. The trial measured the percentage of patients who experienced complete or partial shrinkage of their tumours (overall response rate) and, for patients with a response rate, the length of time the tumour was controlled (duration of response). Of the 88 patients included in the study, 33% experienced complete or partial shrinkage of their tumours. The response lasted for more than 6 months in 86% of responding patients and more than 12 months in 45% of responding patients.
“While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now,” said Dr Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies — even in rare forms of cancer where treatment options are limited or non-existent.”
Through granting accelerated approval, the FDA can approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further trials are required to confirm Bavencio’s clinical benefit.