On March 23, 2017, the FDA accelerated the approval of a new PD-L1 inhibitor, Bavencio (avelumab; from EMD Serono/Pfizer), for the treatment of patients with metastatic Merkel-cell carcinoma, a rare type of cancer. This is the first non-chemotherapy drug and the first immunotherapy approved by the FDA for Merkel-cell carcinoma. It is intended to be used in patients aged 12 years or older.
“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,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.
In the clinical trial that led to the FDA approval, 33% of patients had their tumor shrink partially or entirely, and this lasted for more than 6 months in 86% of the patients and more than 12 months in 45% of the patients.
Common side effects of Bavencio include fatigue, musculoskeletal pain, diarrhea, nausea, rash, reduced appetite, and swelling of the limbs. The most common serious risks of Bavencio are immune-related, where the body’s immune system attacks healthy cells or organs, such as the lungs, liver, colon, glands, and kidneys. In addition, there is a risk of serious infusion-related reactions. Patients who have severe or life-threatening infusion-related reactions should stop using Bavencio.
Bavencio is administered as an intravenous infusion every 2 weeks.