FDA Approves Merkel Cell Carcinoma Injectable


Pfizer Inc. and EMD Serono, a subsidiary of Merck KGaA, have announced that the U.S. Food and Drug Administration (FDA) has approved BAVENCIO (avelumab) injection 20 mg/mL for treatment in adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, a rare and aggressive skin cancer.

Positive Trial Study

The drug was shown effective after 33% of the patients in the trial study saw a response. Of the 88 patients in the trial, 11% saw a complete response and the remaining 22% saw a partial response. The most common side effects were fatigue, musculoskeletal pain, nausea, diarrhea, infusion-related reactions, rash, decreased appetite and peripheral edema. Response time ranged from 2.8 to over 23.3 months.

“At the heart of this FDA approval is our drive to make a meaningful difference for patients with hard-to-treat cancers, like metastatic Merkel cell carcinoma,” said Belén Garijo, CEO healthcare and a member of the executive board of Merck KGaA.

How it Works

BAVENCIO is an anti-PD-L1 antibody, which engages the adaptive and innate immune systems. It works by binding to the PD-L1 human antibody, which then prevents tumor cells from using the PD-L1 as protection from white blood cells.  

“Merkel cell carcinoma is rarer than some of the more well-known skin cancers, however, it’s very aggressive and the proportion of people who die from MCC is much higher than that of people with melanoma. With this approval, I believe there is new hope for people and their families touched by this rare form of skin cancer,” said Deborah S. Sarnoff, M.D., president of the Skin Cancer Foundation. 

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