New Skin Cancer Drug Earns Fast-Tracked Approval

Skin cancer remains the most common type of cancer. Of the several varieties of skin cancer, Merkel cell carcinoma ranks as a more uncommon type, yet it’s aggressive and tends to grow quickly and can be hard to treat once it spreads beyond the skin. Recently, the FDA reviewed a potential new treatment for Merkel cell carcinoma on an accelerated process and granted the treatment – Bavencio® (avelumab) from EMD Serono, Inc.– approval for treating adults (as well as youths 12 years and older) with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy.

Bavencio is currently the first and only FDA-approved treatment for this rare and aggressive skin cancer. This immunotherapy treatment comes in an injection form based on a human anti-PD-L1 antibody that blocks certain interactions of immune proteins which, in turn, improves the body’s immune-related targeting of cancer cells.

Although research with Bavencio will continue, the current study that led to FDA approval of Bavencio included 88 patients with Merkel cell carcinoma. In this study, 33% experienced at least some (or even complete) shrinking of tumors. This tumor regression continued in excess of six months in the majority of patients with a positive response, with 45% of responding patients garnering this benefit for more than a year.

It will surely be a relief to patients and their families facing this form of skin cancer to finally have an FDA-approved treatment option.


Press release. FDA approves first treatment for rare form of skin cancer. March 23, 2017.

Barrett J. FDA grants rare skin cancer drug accelerated approval. Specialty Pharmacy Times March 24, 2017.

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