Patritumab deruxtecan
A HER3-directed ADC with Enhertu's payload, active in lung and all subtypes of breast cancer, but with a bumpy regulatory road.
HERTHENA-Lung01 in EGFR-mutant NSCLC after TKI (ORR ~30%) led to a BLA that received a complete response letter in 2024 over manufacturing; HERTHENA-Lung02 phase 3 was positive for PFS but not OS. In breast cancer, HERTHENA-BC dose-expansion data at ESMO Breast 2026 showed activity across HR+/HER2-, HER2+, and TNBC. Daiichi Sankyo and Merck partnership.
1.Antibody binds HER3 on the tumour cell surface
- Route
- IV infusion
- Schedule
- 5.6 mg/kg every 3 weeks
- Monitoring
- ILD, blood counts
Source: clinicaltrials.gov/study/NCT04619004. Doses are for orientation; the current label governs.
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- 23 Dec 2021DesignationUS
Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI and platinum source
- Dec 2023Filing / dealUS
BLA submitted (HERTHENA-Lung01) source
- 26 Jun 2024Complete response letterUS
Complete response letter citing third-party manufacturing inspection source
- May 2025WithdrawalUS
BLA withdrawn after HERTHENA-Lung02 met PFS but not OS source
| Adverse event |
|---|
| Neutropenia |
| Thrombocytopenia |
| Nausea |
| Fatigue |
| ILD/pneumonitis |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Investigational; BLA withdrawn May 2025 after HERTHENA-Lung02 OS result | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Patritumab deruxtecan" OR ABSTRACT:"Patritumab deruxtecan" OR TITLE:"HER3-DXd" OR ABSTRACT:"HER3-DXd" OR TITLE:"U3-1402" OR ABSTRACT:"U3-1402") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Patritumab deruxtecan, not a curated reading list.