Prescription medicine
Avelumab Brand names: Bavencio
Avelumab (Bavencio) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the avelumab FDA label on DailyMed (effective August 25, 2026, EMD Serono, Inc.); the BLA 761049 record on Drugs@FDA; every avelumab label on DailyMed.
Highlights of the record
FDA label of August 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBAVENCIO 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.
Forms and strengths
- 20 mg/ml
Injection (solution) (concentrate).
On the market
- Earliest approval on file
- March 23, 2017 Bavencio, Emd Serono Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is avelumab used for?
From the label: indications and usageBAVENCIO 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. […]
FDA pharmacologic class: Programmed Death Ligand-1 Blocker.
Source: FDA drug label (BAVENCIO), EMD Serono, Inc., effective August 25, 2026 (SPL set 5cd725a1-2fa4-408a-a651-57a7b84b2118), via openFDA; the full label on DailyMed
What does the patient leaflet for avelumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BAVENCIO?BAVENCIO is a medicine that may treat certain cancers by working with your immune system. BAVENCIO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. […] These are not all of the signs or symptoms of immune system problems that can happen with BAVENCIO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion-related reactions can sometimes be severe or life-threatening. […]
Source: FDA drug label (BAVENCIO), EMD Serono, Inc., effective August 25, 2026 (SPL set 5cd725a1-2fa4-408a-a651-57a7b84b2118), via openFDA; the full label on DailyMed
Is there a generic for avelumab (Bavencio)?
No generic avelumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the avelumab label say about other medicines?
The avelumab label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name avelumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Premedicate with antihistamine and acetaminophen prior to the first 4 infusions. |
| Axitinib | warnings and precautions | Discontinue BAVENCIO in combination with axitinib for Grade 3-4 events. ( 5.4 ) Embryo-fetal toxicity: |
| Prednisone | warnings and precautions | In general, if BAVENCIO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
| Sunitinib | warnings and precautions | MACE occurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib in a randomized trial, JAVELIN Renal 101. |
| Tacrolimus | warnings and precautions | One patient required the addition of tacrolimus to high-dose corticosteroids. |
Source: FDA drug label (BAVENCIO), EMD Serono, Inc., effective August 25, 2026 (SPL set 5cd725a1-2fa4-408a-a651-57a7b84b2118), via openFDA; the full label on DailyMed
What next?
- Other programmed death ligand-1 blockers
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other