ENHERTU (fam-trastuzumab deruxtecan-nxki)
ENHERTU is indicated for the treatment of Unresectable or metastatic HER2-positive breast cancer; Unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer; Unresectable or metastatic HER2-low breast cancer; Unresectable or metastatic HER2-mutant non-small cell lung cancer; Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
How ENHERTU Works
Enhertu consists of a humanized anti-HER2 antibody covalently linked to a topoisomerase I inhibitor payload. After the antibody binds to HER2 receptors on the surface of cancer cells, the complex is internalized and the linker is cleaved by intracellular lysosomal enzymes. The released payload then causes DNA damage and cell death, effectively targeting cells that express the HER2 protein or harbor HER2 mutations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-12-20
- PDUFA Date
- 2026-07-07 (42d)
- Patent Cliff
- 2031
- Revenue
- $756M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ENHERTU Approval History
What ENHERTU Treats
5 indicationsENHERTU is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable or metastatic HER2-positive breast cancer
- Unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer
- Unresectable or metastatic HER2-low breast cancer
- Unresectable or metastatic HER2-mutant non-small cell lung cancer
- Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
ENHERTU Boxed Warning
INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms [see Dosage and Administration (2.3) , Warnin...
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ] . WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. ( 2.3 , 5.1 ) Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception. ( 5.4 , 8.1 , 8.3 )
ENHERTU Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
ENHERTU Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ENHERTU's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ENHERTU treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06610825 CaRPET | 1803020 | Ph 2 | recruiting | Castrate Resistant Prostate Cancer Enhertu Therapy |
| NCT05650879 HER2 | ELVN-002-001 | Ph 1 | active not recruiting | ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer |
| NCT05868226 PRE-I-SPY-PI | I-SPY-P1 | Ph 1 | recruiting | PRE-I-SPY Phase I/Ib Oncology Platform Program |
| NCT05097599 StrataPATH | STR-004-001 KEYNOTE-F04 | Ph 2 | terminated | StrataPATH™ (Precision Indications for Approved Therapies) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENHERTU FDA Label Details
Indications & Usage
FDA Label (PDF)ENHERTU is indicated for the treatment of Unresectable or metastatic HER2-positive breast cancer; Unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer; Unresectable or metastatic HER2-low breast cancer; Unresectable or metastatic HER2-mutant non-small cell lung cancer; Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory sympto...
Pro Intelligence Preview
Deep insights for ENHERTU
Revenue Insights
- • Q4-2025: $756M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • 4 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment