EMD Serono, U.S. company focused on specialty care has received U.S. Food and Drug Administration (FDA) approval for its rare skin cancer drug.
The FDA has granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy.
FDA said that this is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer.
“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 Richard Pazdur, M.D., 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 approval was 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 FDA gave the drug the Accelerated Approval, the approval the FDA gives drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients, but further clinical trials to confirm drugs clinical benefit need to be done.
Also, the FDA granted this application Priority Review and Breakthrough Therapy designation. Bavencio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
According to the National Cancer Institute, approximately 1,600 people in the United States are diagnosed with MCC every year. While the majority of patients present with localized tumors that can be treated with surgical resection, approximately half of all patients will experience recurrence, and more than 30 percent will eventually develop metastatic disease. In patients with metastatic MCC, the cancer has spread beyond the skin into other parts of the body, FDA said.