FDA Accelerated Approval for Merkel Cell Carcinoma Treatment
The U.S. Food and Drug Administration granted accelerated approval to Bavencio, based on data from a single-arm trial of 88 patients. Bavencio is now the first FDA-approved treatment for metastatic Merkel Cell Carcinoma (MCC)–a rare but highly aggressive form of skin cancer.
According to the FDA released statement, approximately 1,600 people in the United States are diagnosed with MCC every year. 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.
“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.
“AEIOU” and how it can save your life
Merkel cell carcinoma usually appears as a single painless lump on sun-exposed skin.
A: Asymptomatic/lack of tenderness
E: Expanding rapidly
I: Immune suppression
O: Older than 50 years
U: Ultraviolet-exposed/fair skin
Specialist doctor from the University Hospital in Gothenburg, alumnus UC Berkeley. My doctoral dissertation is about Digital Health and I have published 5 scientific articles in teledermatology and artificial intelligence.