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

Is Pembrolizumab
FDA approved?

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

FDA Approved
FDA status
PD-1 Checkpoint Inhibitor / Multiple Cancers
Drug category
https://www.drugs.com/price-guide/keytruda
Last reviewed
Drug status summary

Pembrolizumab

FDA Approved

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

Brand names
Keytruda
Prescription status
Merck support programs may apply
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

Pembrolizumab approval status and regulatory context

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What DrugStatusIndex currently shows

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

Regulatory note: Pembrolizumab estimated cash pricing: $10,000-$15,000 per infusion/claim. Coupon pricing usually not applicable; oncology billing channel. Pricing varies by dose, quantity, pharmacy, location, insurance, and current savings programs.
FDA status
FDA Approved
Drug category
PD-1 Checkpoint Inhibitor / Multiple Cancers
Prescription status
Merck support programs may apply
Availability note
Medical benefit billing; authorization and site-of-care rules apply

Index review fields

Review status
$10,000-$15,000 per infusion/claim
Last checked
Coupon pricing usually not applicable; oncology billing channel
Published
Yes
Page URL
https://drugstatusindex.com/is-pembrolizumab-fda-approved/
Pricing and access

Pembrolizumab 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 Pembrolizumab 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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