Overview
Trastuzumab deruxtecan is a HER-2 directed antibody attached to a topoisomerase inhibitor that is approved for use in certain types of metastatic, unresectable breast cancer. It is classified as an antibody-drug conjugate. The cleavable peptide linker used to bind the antibody and drug in this product distinguishes it from other members of its class. Trastuzumab deruxtecan has been granted FDA approval for specific patients with HER-2 positive breast cancer who have failed other treatments. Promising results from a clinical trial prompted accelerated FDA approval for this indication on December 20, 2019. Trastuzumab deruxtecan was developed by Daiichi Sankyo in collaboration with AstraZeneca. In May 2022, trastuzumab deruxtecan was fully approved by the FDA.
Indication
In the US, trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. It is also indicated to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Trastuzumab deruxtecan is also indicated to treat adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. In Canada, trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously been treated with trastuzumab emtansine, or who have received at least one prior anti-HER2-based regimen either in the metastatic setting or in the adjuvant/neoadjuvant setting who have experienced disease recurrence during or within 6 months of adjuvant/neoadjuvant therapy. Trastuzumab deruxtecan is also indicated in Canada for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. In Europe, trastuzumab deruxtecan is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens and unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. It is also indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Associated Conditions
- Advanced Gastric Adenocarcinoma
- Advanced Gastroesophageal Adenocarcinoma
- Metastatic Breast Cancer
- Metastatic Breast Cancer With HER2 Positive
- Unresectable Breast Cancer
- Locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction
- Locally advanced HER2-positive Gastric Adenocarcinoma
- Metastatic HER2 Mutant Non-small Cell Lung Cancer
- Metastatic HER2-low Breast Cancer
- Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction
- Metastatic HER2-positive Gastric Adenocarcinoma
- Unresectable HER2 Mutant Non-small Cell Lung Cancer
- Unresectable HER2-low Breast Cancer
- Unresectable HER2/Neu-positive Breast Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/06/15 | Phase 3 | Not yet recruiting | |||
2025/06/11 | Phase 1 | Not yet recruiting | |||
2025/06/10 | Phase 1 | Not yet recruiting | |||
2025/05/25 | Phase 3 | Recruiting | |||
2025/03/27 | Phase 3 | Not yet recruiting | |||
2025/02/18 | Phase 2 | Recruiting | Shanghai Henlius Biotech | ||
2025/02/11 | Phase 3 | Recruiting | |||
2025/01/09 | Phase 3 | Recruiting | |||
2024/12/27 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Daiichi Sankyo Inc. | 65597-406 | INTRAVENOUS | 100 mg in 5 mL | 2/22/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/18/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL | SIN16352P | INFUSION, SOLUTION CONCENTRATE | 100 mg/vial | 10/22/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan for Injection | 国药准字SJ20230005 | 生物制品 | 注射剂 | 3/24/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG | N/A | N/A | N/A | 12/14/2021 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ENHERTU trastuzumab deruxtecan 100 mg powder for injection vial | 343262 | Medicine | A | 10/8/2021 |
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