Adults and children older than 12 years old with metastatic Merkel cell carcinoma (MCC) will now have access to the anti-PD-L1 immunotherapy Bavencio (avelumab) in the United States.
It is the first treatment the Food and Drug Administration has approved for MCC, a rare and aggressive form of skin cancer.
“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,” Richard Pazdur, MD, an FSA scientist, said in a news 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 non-existent.”
Pazdur is the 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.
Nearly 1,600 people are diagnosed with MCC every year in the United States, according to National Cancer Institute estimates.
Most patients’ have localized tumors that are treated with surgery. The cancer returns in about half of patients, and in a third the cancer metastasizes, or spreads to other areas of the body. The mestastiis group has lacked treatment options.
Bavencio is an anti-PD-L1 antibody designed to block the signal that tells immune cells to leave cancer cells unharmed.
Its safety and effectiveness in Merkel cell carcinoma was assessed in a Phase 2 trial, the JAVELIN Merkel 200 trial (NCT02155647), whose results were published in the renowned journal The Lancet Oncology.
The trial enrolled 88 patients with metastatic MCC who had received at least one chemotherapy regimen. Thirty-three percent of the patients responded to Bavencio, experiencing either a full or a partial regression of their tumors.
The duration of response was longer than six months in 86 percent of the patients who responded, and it lasted more than a year in 45 percent of those who responded.
Based on preliminary data from the trial, the FDA granted priority review and breakthrough therapy designation to Bavencio for treating metastatic MCC. Bavencio was also granted orphan drug status, a designation that gives pharmaceutical companies incentives to develop drugs for rare diseases.
Now, the FDA has approved the drug for metastatic MCC patients 12 years and older, including those who did not receive prior chemotherapy.