Sign in

FDA Approves Merkel Cell Carcinoma Injectable

Contact Author
Close

Thank you for your inquiry. Please note that the author cannot provide individual medical advice. Also, if you have a customer service question, email customer service at customerservice@skininc.com

Fill out my online form.
Skin cancer

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. 

Related Content