FDA Grants Rare Skin Cancer Drug Accelerated Approval

Bavencio (avelumab) is indicated to treat metastatic Merkel cell carcinoma.

The FDA granted accelerated approval to the first treatment for metastatic Merkel cell carcinoma (MCC). EMD Serono’s Bavencio (avelumab) is indicated to treat this rare and aggressive form of skin cancer in adults and pediatric patients 12 years and older, including those who have not received prior chemotherapy.

The FDA’s accelerated approvals are given to drugs for serious conditions to fill an unmet medical need using trial data that support the drug’s clinical benefit for patients. Further studies are needed, and are currently being conducted, to confirm Bavencio’s efficacy.

Bavencio’s accelerated approval is based on clinical data from a trial including 88 patients with metastatic MCC who had been previously treated with at least 1 prior chemotherapy regimen. Of the patients who received Bavencio in the trial, 33% experienced complete or partial tumor shrinkage.

Bavencio is designed to help the body’s immune system attack cancer cells by targeting the PD-1/PD-L1 pathway.

Adverse effects commonly reported with Bavencio include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and swelling of the limbs (peripheral edema).


FDA approves first treatment for rare form of skin cancer [news release]. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Released March 23, 2017. Accessed March 23, 2017.