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FDA approves Bavencio for metastatic Merkel cell carcinoma

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The FDA today granted accelerated approval to avelumab for the treatment of patients aged 12 years and older with metastatic Merkel cell carcinoma.

The approval of avelumab (Bavencio; EMD Serono, Pfizer) includes use of the agent among patients who have not received chemotherapy.

“[Although] 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,” 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, said in a press release. “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 nonexistent.”

An estimated 1,600 Americans are diagnosed with Merkel cell carcinoma each year, according to NCI. Most patients present with localized tumors and undergo surgical resection; however, nearly half of patients develop recurrence, and approximately one-third will develop metastatic disease, according to FDA.

Avelumab, a fully human anti–PD-L1 IgG1 monoclonal antibody, targets the PD-1/PD-L1 pathway and helps the body’s immune system attack cancer cells.

The FDA based its approval on results of a single-arm trial that included 88 patients with metastatic Merkel cell carcinoma who underwent at least one previous chemotherapy regimen. Researchers assessed overall response rate and duration of response.

One-third (33%) of patients who received avelumab experienced complete or partial tumor shrinkage. The majority (86%) of responses lasted more than 6 months, and nearly half (45%) lasted more than 12 months.

Common side effects associated with avelumab include fatigue, musculoskeletal pain, diarrhea, nausea, rash, decreased appetite, swelling of the limbs and infusion-related reactions.

The most common serious side effects are immune-mediated, such as pneumonitis, hepatitis, colitis, endocrinopathies and nephritis.