FDA approved Bavencio (avelumab) for Metastatic Merkel Cell CarcinomaFDA approved new drug Bavencio for rare skin cancer

FDA From the archive Source published March 23, 2017 Summary added September 3, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Bavencio for metastatic MCC, but monitor for immune-mediated adverse reactions.

The U.S. Food and Drug Administration has approved Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), a rare and aggressive form of skin cancer. This is the first FDA-approved therapy for this indication, offering a new option for a disease with limited treatment choices.

Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody that works by helping the immune system fight cancer cells. The approval was based on data from a clinical trial that demonstrated durable responses in a subset of patients. The recommended dose is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Clinicians should be aware of the potential for immune-mediated adverse reactions, which may require dose modification or discontinuation. Premedication with an antihistamine and acetaminophen is recommended for the first four infusions to manage infusion-related reactions.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody. It binds to PD-L1 and blocks its interaction with PD-1 and B7.1 receptors, removing the suppression of the antitumor immune response.

Indication & Patient Population

BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).

Dosing & Administration

The recommended dosage is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions. Subsequent premedication should be based on clinical judgment and prior infusion reactions. No dose reduction is recommended. Withhold for severe (Grade 3) immune-mediated adverse reactions; permanently discontinue for life-threatening (Grade 4) reactions, recurrent severe reactions requiring systemic immunosuppression, or inability to reduce corticosteroid dose to 10 mg or less prednisone equivalent per day within 12 weeks.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, and others, may occur. Infusion-related reactions have been reported. No contraindications are listed in the label.

Place in Therapy

BAVENCIO is the first FDA-approved treatment for metastatic Merkel cell carcinoma. It provides a new therapeutic option for this rare malignancy, where prior treatments were limited.

The U.S. Food and Drug Administration has approved a new medicine called Bavencio (avelumab) for adults and children aged 12 and older with a rare and aggressive type of skin cancer called metastatic Merkel cell carcinoma. This is the first FDA-approved treatment for this disease, which previously had very few options.

Bavencio works by helping the body's immune system recognize and attack cancer cells. It is given as an intravenous infusion over 60 minutes every two weeks. The approval is based on a clinical trial that showed some patients had lasting responses to the treatment.

Like all medicines, Bavencio can cause side effects. Some of these are related to the immune system, and some patients may experience reactions during the infusion. Doctors are advised to give certain medications before the first few infusions to help prevent these reactions.

This approval is a significant step forward for people with this rare cancer. However, it is not a cure for everyone, and it may not be suitable for all patients. If you or a loved one has Merkel cell carcinoma, talk to your doctor about whether Bavencio might be an option and what to expect from treatment.

What this means for you:

Bavencio offers a new treatment option for a rare skin cancer, but talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval

PublishedMar 2017

View Original Abstract ↓

1 INDICATIONS AND USAGE BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. ( 1.1 , 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. ( 1.2 , 14.2 ) Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy. ( 1.2 , 14.2 ) Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.2 , 14.2 ) Renal Cell Carcinoma (RCC) First-line treatment, in combination with axitinib, of patients with advanced RCC. ( 1.3 , 14.3 ) 1.1 Metastatic Merkel Cell Carcinoma BAVENCIO (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) [see Clinical Studies (14.1) ] . 1.2 Locally Advanced or Metastatic Urothelial Carcinoma First-Line Maintenance Treatment of Urothelial Carcinoma BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy [see Clinical Studies (14.2) ] . Previously-treated Urothelial Carcinoma BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy [see Clinical Studies (14.2) ]. 1.3 Advanced Renal Cell Carcinoma BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC) [see Clinical Studies (14.3) ] .

FDA approved Bavencio (avelumab) for Metastatic Merkel Cell CarcinomaFDA approved new drug Bavencio for rare skin cancer

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FDA approved Bavencio (avelumab) for Metastatic Merkel Cell CarcinomaFDA approved new drug Bavencio for rare skin cancer

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Clinical research that matters. Delivered to your inbox.

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