Drug updated on 10/29/2024
| Dosage Form | Injection (intravenous; 100 mg/vial) |
| Drug Class | HER2/neu receptor antagonists and topoisomerase inhibitor conjugates |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received two or more prior anti-HER2-based regimens 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
- Indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
- Indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy
- Indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen
- Indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Latest News
Summary
- This summary is based on the review of 19 systematic review(s)/meta-analysis(es). [1-19]
- Trastuzumab deruxtecan demonstrated significant effectiveness in HER2-low/positive advanced breast cancer, HER2-positive breast cancer brain metastases, HER2-expressing salivary gland carcinoma, HER2-positive solid tumors, and advanced gastric or gastroesophageal junction carcinoma.
- In HER2-positive breast cancer brain metastases, the median progression-free survival (PFS) was 15 months, with an overall response rate (ORR) of 61% and a clinical benefit rate (CBR) of 80%.
- In HER2-expressing salivary gland carcinoma, the ORR was 58.8%, with a median duration of response (DoR) of 17.6 months and PFS of 20.5 months.
- In advanced gastric cancer or gastroesophageal junction carcinoma, trastuzumab deruxtecan significantly improved overall survival (OS) and PFS compared to chemotherapy.
- The most common treatment-emergent adverse events (TEAEs) included nausea, fatigue, and neutropenia, with grade ≥3 TEAEs primarily involving neutropenia. Incidences of interstitial lung disease (ILD) and/or pneumonitis were 12.5% (all-grade) and 2.2% (grade ≥3).
- In patients with HER2-expressing salivary gland carcinoma, the most common TEAEs were decreased appetite (94.1%), nausea (88.2%), and decreased neutrophil count (76.5%), with serious ILD events occurring in 29.4% of patients (grade ≥3).
- There is no information available on population types or subgroups.
- Serious ILD and pneumonitis events were noted across HER2-positive solid tumors, while cardiotoxicity (decreased LVEF (left ventricular ejection fraction) and QT (QTi) interval prolongation) was observed less frequently.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Enhertu (fam-trastuzumab deruxtecan-nxki) Prescribing Information. | 2024 | Daiichi Sankyo Inc., Basking Ridge, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: ASCO-College of American Pathologists Guideline Update | 2023 | Journal of Clinical Oncology |
| Immunotherapy and Targeted Therapy for Advanced Gastroesophageal Cancer: ASCO Guideline | 2023 | Journal of Clinical Oncology |
| Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: ASCO Guideline Update | 2022 | Journal of Clinical Oncology |
| ESMO clinical practice guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. | 2021 | Annals of Oncology |
| Treating breast cancer. | 2020 | American Cancer Society |