Fam-trastuzumab deruxtecan is listed for DrugStatusIndex cancer drug review with a working oncology status of FDA approved or FDA-recognized use under approved labeling.
FDA Regulatory Database

Is Fam-trastuzumab deruxtecan
FDA approved?

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

FDA Approved
FDA status
HER2 Antibody-Drug Conjugate / Breast
Drug category
Coverage and prior authorization vary by plan, dose, pharmacy, and diagnosis.
Last reviewed
Drug status summary

Fam-trastuzumab deruxtecan

FDA Approved

Enhertu

Brand names
Gastric
Prescription status
$14,000-$18,000 per cycle
Compounded status
Lung Cancer
Confusion level
Commercial FDA-approved oncology products or approved generics may be available; compounding is generally not appropriate when approved products meet patient needs.
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

Fam-trastuzumab deruxtecan approval status and regulatory context

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Enhertu

Regulatory note: Manufacturer or patient-assistance savings may apply for brand/specialty products
FDA status
FDA Approved
Drug category
HER2 Antibody-Drug Conjugate / Breast
Prescription status
$14,000-$18,000 per cycle
Availability note
$13,000-$17,000 specialty estimate

Index review fields

Review status
Check whether Fam-trastuzumab deruxtecan is FDA approved, its cancer treatment category, prescription status, availability, and key regulatory notes for 2026.
Last checked
https://www.cancer.gov/about-cancer/treatment/drugs/cancer-drugs
Published
Yes
Page URL
https://drugstatusindex.com/is-fam-trastuzumab-deruxtecan-fda-approved/
Pricing and access

Fam-trastuzumab deruxtecan pricing information

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

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Coupon estimate
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Pricing last checked
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Pricing summary

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Coverage and savings notes

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Sources and verification

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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.

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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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