Avelumab FDA Approval Status (2026) – Approved or Not?
FDA Regulatory Database

Is Avelumab
FDA approved?

DrugStatusIndex.com provides a plain-English status page for Avelumab, including FDA approval status, prescription classification, compounding context, pricing information, and regulatory notes.

FDA Approved
FDA status
PD-L1 Checkpoint Inhibitor / Merkel Cell and Urothelial Cancer
Drug category
https://www.goodrx.com/bavencio
Last reviewed
Drug status summary

Avelumab

FDA Approved

Avelumab is listed for DrugStatusIndex cancer drug review with a working oncology status of FDA approved or FDA-recognized use under approved labeling.

Brand names
Bavencio
Prescription status
Manufacturer or patient-assistance savings may apply for brand/specialty products
Compounded status
Commercial FDA-approved oncology products or approved generics may be available; compounding is generally not appropriate when approved products meet patient needs.
Confusion level
High
FDA Approved Approved for commercial use in the US
Not Approved Not cleared by FDA for use
Investigational Under review or in clinical trials
Rx Only Prescription required — not OTC
FDA approval status

Avelumab approval status and regulatory context

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What DrugStatusIndex currently shows

Avelumab is listed for DrugStatusIndex cancer drug review with a working oncology status of FDA approved or FDA-recognized use under approved labeling.

Regulatory note: Avelumab estimated cash pricing: $13,000-$16,000 per cycle. Discount/coupon estimate: $12,000-$15,000 specialty estimate. Pricing varies by dose, quantity, pharmacy, location, insurance, and current savings programs.
FDA status
FDA Approved
Drug category
PD-L1 Checkpoint Inhibitor / Merkel Cell and Urothelial Cancer
Prescription status
Manufacturer or patient-assistance savings may apply for brand/specialty products
Availability note
Coverage and prior authorization vary by plan, dose, pharmacy, and diagnosis.

Index review fields

Review status
$13,000-$16,000 per cycle
Last checked
$12,000-$15,000 specialty estimate
Published
Yes
Page URL
https://drugstatusindex.com/is-avelumab-fda-approved/
Pricing and access

Avelumab pricing information

Pricing can vary by dose, pharmacy, insurance coverage, manufacturer savings, coupon programs, market availability, and current supply conditions.

Retail estimate
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Estimated cash or retail pricing range when available.

Coupon estimate
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Discount-card or pharmacy coupon estimate when available.

Pricing last checked
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Pricing data should be rechecked before making financial or treatment decisions.

Pricing summary

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Coverage and savings notes

Manufacturer savings: {pricing_manufacturer_savings}

Insurance note: {pricing_insurance_note}

Sources and verification

Verify Avelumab directly with trusted source material

DrugStatusIndex.com is an informational resource. FDA status, availability, and pricing should be independently verified using official FDA resources, pharmacy data, prescribing information, and licensed healthcare guidance.

FDA / regulatory source
https://www.cancer.gov/about-cancer/treatment/drugs/cancer-drugs
Pricing source
{pricing_source_url}

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Informational resource only
DrugStatusIndex.com reflects publicly available FDA regulatory data and does not provide medical advice, diagnosis, treatment recommendations, pharmacy recommendations, or legal/regulatory advice. Always consult a licensed healthcare provider before making any medical decision.
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