PMDA approves ENHERTU for HER2-low breast cancer in Japan
Decision brief
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PMDA approved ENHERTU for unresectable or metastatic HER2-low breast cancer in Japan, marking a new regulatory catalyst for Daiichi Sankyo and AstraZeneca. The decision expands the drug’s labeled use in a major market and adds another milestone for investors tracking ENHERTU.
Key questions this brief answers
- What did PMDA approve for ENHERTU in Japan?
- Who manufactures ENHERTU?
- What is ENHERTU's mechanism of action?
- What are ENHERTU's FDA-approved indications in the United States?
- What clinical trials are investigating trastuzumab deruxtecan?
The Pharmaceuticals and Medical Devices Agency (PMDA) has approved ENHERTU for adult patients with unresectable or metastatic HER2-low breast cancer in Japan. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate manufactured by Daiichi Sankyo Inc.
Contents13 sections
PMDA approves ENHERTU for HER2-low breast cancer in Japan
PMDA approval: what changed in Japan
The Pharmaceuticals and Medical Devices Agency (PMDA) has approved ENHERTU for adult patients with unresectable or metastatic HER2-low breast cancer in Japan. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate, administered intravenously. The generic name is fam-trastuzumab deruxtecan-nxki, manufactured by Daiichi Sankyo Inc.
ENHERTU's regulatory footprint extends beyond Japan
In the United States, ENHERTU is FDA-indicated for HER2-positive early breast cancer as neoadjuvant treatment and as adjuvant treatment of adult patients with HER2-positive breast cancer. The Japan approval introduces a distinct indication—HER2-low metastatic disease—that differs from the U.S. label, which focuses on HER2-positive early breast cancer.
Clinical trials involving trastuzumab deruxtecan
A Phase 3 trial (NCT05113251) is evaluating trastuzumab deruxtecan alone or in sequence with taxane, trastuzumab, and pertuzumab versus standard treatment in HER2-positive early breast cancer.
Key Takeaways
- PMDA approved ENHERTU for adult patients with unresectable or metastatic HER2-low breast cancer in Japan.
- ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate manufactured by Daiichi Sankyo Inc.
- In the United States, ENHERTU is FDA-indicated for HER2-positive early breast cancer as neoadjuvant and adjuvant treatment, representing a different patient population and HER2 expression profile than the Japan indication.
- Clinical trials are investigating trastuzumab deruxtecan in HER2-low and HER2-positive breast cancer settings.
Drug Snapshot
| Drug | fam-trastuzumab deruxtecan-nxki |
|---|---|
| Generic name | FAM-TRASTUZUMAB DERUXTECAN-NXKI |
| Manufacturer | Daiichi Sankyo Inc. |
| Route | INTRAVENOUS |
| Indication | 1 INDICATIONS AND USAGE ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP). ( 1.1 ) as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. ( 1.1 ) HER2-Positive |
Regulatory Summary
- Approved indication: 1 INDICATIONS AND USAGE ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP). ( 1.1 ) as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. ( 1.1 ) HER2-Positive
- Daiichi Sankyo Inc. develops fam-trastuzumab deruxtecan-nxki
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT07198724 | ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer | RECRUITING | PHASE1, PHASE2 | Kristina A. Fanucci |
| NCT05704829 | NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer | RECRUITING | PHASE2 | West German Study Group |
| NCT05113251 | Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer | ACTIVE_NOT_RECRUITING | PHASE3 | AstraZeneca |
| NCT07060807 | A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) | RECRUITING | PHASE3 | Merck Sharp & Dohme LLC |
| NCT07007559 | ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer | RECRUITING | PHASE2 | ALX Oncology Inc. |
Competitor Matrix
| Company / Program | Indication | Active trials |
|---|---|---|
| Hoffmann-La Roche | breast cancer | 2 |
| Virginia Commonwealth University | breast cancer | 1 |
| Genentech, Inc. | breast cancer | 1 |
| Pfizer | breast cancer | 1 |
| Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco | breast cancer | 1 |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | breast cancer | 1 |
Timeline
- Recruiting trial NCT07198724 (PHASE1, PHASE2)
- Recruiting trial NCT05704829 (PHASE2)
- Active_Not_Recruiting trial NCT05113251 (PHASE3)
- Recruiting trial NCT07060807 (PHASE3)
- Recruiting trial NCT07007559 (PHASE2)
Frequently Asked Questions
What did PMDA approve for ENHERTU in Japan?
PMDA approved ENHERTU for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer in Japan.
Who manufactures ENHERTU?
ENHERTU (fam-trastuzumab deruxtecan-nxki) is manufactured by Daiichi Sankyo Inc.
What is ENHERTU's mechanism of action?
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate administered intravenously.
What are ENHERTU's FDA-approved indications in the United States?
In the United States, ENHERTU is FDA-indicated for HER2-positive early breast cancer as neoadjuvant treatment and as adjuvant treatment of adult patients with HER2-positive breast cancer.
What clinical trials are investigating trastuzumab deruxtecan?
A Phase Ib/II trial (NCT07198724) is exploring trastuzumab deruxtecan combined with elacestrant in HR+/HER2-low or HER2-ultralow metastatic breast cancer. A Phase 3 trial (NCT05113251) is evaluating trastuzumab deruxtecan in HER2-positive early breast cancer.
How does the Japan indication differ from the U.S. label?
The Japan approval covers HER2-low metastatic breast cancer, whereas the FDA-approved indications in the United States focus on HER2-positive early breast cancer, representing different patient populations defined by HER2 expression levels.
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