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Bavencio® Approved as First Agent Ever for Merkel Cell Carcinoma

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The United States Food and Drug Administration (FDA) has approved the agent Bavencio (avelumab) for the treatment of advanced merkel cell carcinoma (MCC) in both adult and pediatric patients. The approval is indicated for patients whose cancer has spread to distant sites in the body, whether or not they have received prior therapy.


Merkel cell carcinoma is a rare type of skin cancer, affecting approximately 1,600 people in the United States each year. If detected early, MCC can be removed surgically. However, 30% of patients develop metastatic MCC, whereby cancer spread from its site of origin to distant and/or several sites in the body. MCC is considered to be an aggressive type of cancer, and until now, no agent has been approved specifically for MCC.


Bavencio targets the PD-1/PD-L1 pathway, a cellular pathway whereby cancer cells are able to manipulate the immune system to not attack them. Bavencio disables a cancer cell’s ability to evade immune cells through the PD-1/PD-L1 pathway, so the immune system can initiate an attack against the cancer.


The trial that prompted the approval of Bavencio included 88 patients with metastatic MCC who had received at least one prior chemotherapy regimen. All patients were treated with Bavencio.


• 33% of patients achieved a partial or complete disappearance of their cancer.
• Of the patients who achieved an anti-cancer response, 86% had responses lasting more than 6 months, and 45% had a response lasting more than one year.
• Common side effects include fatigue, pain in the muscles and bone and gastrointestinal symptoms.


In the FDA press release announcing the approval of Bavencio, 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 stated that “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,” “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.”


Patients diagnosed with advanced MCC may wish to speak with their physician regarding their individual risks and benefits associated with treatment including Bavencio.


Reference: United States Food and Drug Administration (FDA). FDA News Release. FDA approves first treatment for rare form of skin cancer. Accessed June 23, 2017. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm

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