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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/12 | Phase 3 | Recruiting | |||
2024/12/10 | N/A | Recruiting | |||
2024/10/08 | Phase 2 | Not yet recruiting | Jeeyun Lee | ||
2024/09/24 | Phase 2 | Recruiting | Washington D.C. Veterans Affairs Medical Center | ||
2024/08/13 | N/A | Recruiting | Sun Yat-sen University | ||
2024/08/12 | Phase 2 | Not yet recruiting | |||
2024/08/01 | Phase 2 | Recruiting | Ana C Garrido-Castro, MD | ||
2024/07/29 | Phase 1 | Recruiting | |||
2024/06/21 | Phase 3 | Recruiting | |||
2024/06/03 | Phase 2 | Recruiting |
FDA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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