The Food and Drug Administration (FDA) has approved the first medication to treat a rare but aggressive form of skin cancer called Merkel cell carcinoma (MCC).
Skin cancer is one of the most common cancers, but MCC is rare with only about 1,600 people in the U.S. diagnosed each year. It usually appears as a flesh-colored or bluish-red nodule most often seen on the face, head or neck. Most patients with MCC are diagnosed with localized tumors that can be treated with surgical resection, but about half of them will experience a recurrence and the disease will spread in more than 30 percent of patients.
Avelumab is a novel immunotherapy. It acts as an inhibitor of the programmed cell death, or PD, pathway. This is the only indication for this drug at this time. Its approval was based on clinical trials involving 88 patients with MCC who did not respond to chemotherapy. A third of the patients in the study experienced complete or partial shrinkage of their tumors, which lasted for more than six months in 86 of those patients, and more than 12 months in 45 percent of those 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 Richard Pazdur, MD, 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.
“Achieving rapid, durable responses are difficult in this population of patients who have already progressed on chemotherapy,” corresponding author Howard L. Kaufman, MD, associate director for clinical science at Rutgers Cancer Institute of New Jersey, New Brunswick, told Medscape Medical News. “It is a significant advancement for avelumab to show an impact in this setting.”
Avelumab side effects noted during the clinical trial include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and peripheral edema. The most common serious side effects were immune-mediated and include pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis.