Fam-trastuzumab deruxtecan-nxki

(Enhertu®)

Enhertu®

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Drug updated on 4/18/2024

Dosage FormInjection (intravenous; 100 mg/vial)
Drug ClassHER2-directed antibodies and topoisomerase inhibitor conjugates
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with unresectable or metastatic HER2-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 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.

Summary
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  • Fam-trastuzumab deruxtecan-nxki (Enhertu) is indicated for the treatment of adult patients with various types of unresectable or metastatic cancers, including HER2-positive breast cancer, HER2-low breast cancer, non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction adenocarcinoma, and solid tumors. The drug has shown promising results in these indications.
  • A total of 49 systematic reviews/meta-analyses were reviewed to gather information about Enhertu's efficacy and safety across its various indications. These studies compared Enhertu with other treatments such as trastuzumab-based regimens, lapatinib, tucatinib, and standard chemotherapies.
  • In cases of HER2-positive metastatic breast cancer, especially after prior anti-HER2-based treatments have been used without success, Enhertu demonstrated superior efficacy when compared to trastuzumab emtansine (T-DM1) and other anti-HER2 therapies.
  • For early-stage or locally advanced HER2-positive breast cancers treated in a neoadjuvant setting; while pyrotinib and lapatinib combined with trastuzumab showed high pathological complete response rates, the management of adverse events was challenging, particularly with pyrotinib use.
  • When treating Non-Small Cell Lung Cancer (NSCLC), Enhertu displayed notable effectiveness, offering substantial progression-free survival benefits over existing therapies. It also proved useful in treating solid tumors where no satisfactory treatment options exist beyond those for breast cancer.
  • In patients suffering from advanced HER2-positive gastric cancers who had previously undergone a trastuzumab-based regimen, the use of Enhertu resulted in effective outcomes similar to those seen within the metastatic breast cancer settings.
  • The risk of cardiotoxicity associated with anthracycline & Trastuzumab treatments necessitates the use of protective strategies. The studies support Enhertu's favorable safety profile with manageable side effects in comparison to conventional therapies, although vigilance for interstitial lung disease/pneumonitis is advised.
  • Enhertu's broad efficacy across different cancers and treatment lines signifies its role in addressing unmet medical needs, particularly in HER2-positive patients facing limited options. Its benefit extends to various subgroups including those with brain metastases and those who have rapidly progressed on previous therapies, suggesting a versatile role within cancer treatment protocols.

Product Monograph / Prescribing Information

Document TitleYearSource
Enhertu (fam-trastuzumab deruxtecan-nxki) Prescribing Information.2024Daiichi Sankyo Inc., Basking Ridge, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A systematic review of health-related quality of life in women with HER2-positive metastatic breast cancer treated with trastuzumab.2024PharmacoEconomics
Safety and efficacy of pyrotinib for HER‑2‑positive breast cancer in the neoadjuvant setting: a systematic review and meta‑analysis.2024Oncology Letters
Trastuzumab deruxtecan in human epidermal growth factor receptor 2-positive breast cancer brain metastases: a systematic review and meta-analysis.2024ESMO Open
Efficacy and safety of first-line therapy in patients with HER2-positive advanced breast cancer: a network meta-analysis of randomized controlled trials.2024Journal of Cancer Research and Clinical Oncology
Efficacy and safety of trastuzumab deruxtecan in breast cancer: a systematic review and meta-analysis.2023Clinical Breast Cancer
ACEI/ARB and beta-blocker therapies for preventing cardiotoxicity of antineoplastic agents in breast cancer: a systematic review and meta-analysis.2023Heart Failure Reviews
The value of neoadjuvant anthracycline-based regimens for HER2-positive breast cancer: a systematic review and meta-analysis including 1366 patients.2023Clinical Medicine Insights
Safety profile of trastuzumab-emtansine (T-DM1) with concurrent radiation therapy: a systematic review and meta-analysis.2023Radiotherapy and Oncology
Landscape of neoadjuvant therapy in HER2-positive breast cancer: a systematic review and network meta-analysis.2023European Journal of Cancer
Efficacy and safety of trastuzumab deruxtecan in patients with solid tumors: a systematic review and meta-analysis of 3 randomized controlled trials.2023American Journal of Cancer Research
The efficacy and safety of trastuzumab deruxtecan (T-DXd) in HER2-expressing solid tumours: a single-arm meta-analysis.2023Japanese Journal of Clinical Oncology
Efficacy and safety of trastuzumab deruxtecan in the treatment of HER2-low/positive advanced breast cancer: a single-arm meta-analysis.2023Frontiers in Pharmacology
Intrathecal trastuzumab versus alternate routes of delivery for HER2-targeted therapies in patients with HER2+ breast cancer leptomeningeal metastases.2023The Breast
Identifying the optimal therapeutics for patients with hormone receptor-positive, HER2-positive advanced breast cancer: a systematic review and network meta-analysis.2023ESMO Open
Pathologic complete response achieved in early-stage HER2-positive breast cancer after neoadjuvant therapy with trastuzumab and chemotherapy vs. trastuzumab, chemotherapy, and pertuzumab: a systematic review and meta-analysis of clinical trials.2023Cureus
Health-related quality of life in HER2-positive early breast cancer woman using trastuzumab: a systematic review and meta-analysis.2023Frontiers in Pharmacology
Adjuvant treatment with trastuzumab of patients with HER2-positive, T1a-bN0M0 breast tumors: a systematic review and meta-analysis.2023Critical Reviews in Oncology/Hematology
Neoadjuvant therapy with vs. without anthracyclines for HER2-positive breast cancer: a systematic review and meta-analysis.2023Frontiers in Oncology
Comparison of the efficacy and safety of third-line treatments for advanced gastric cancer: a systematic review and network meta-analysis.2023Frontiers in Oncology
Treatment-related adverse events associated with HER2-Targeted antibody-drug conjugates in clinical trials: a systematic review and meta-analysis.2022eClinicalMedicine
Axillary downstaging and the impact of clinical axillary status on efficacy of neoadjuvant therapy for HER2-positive breast cancer: a network meta-analysis.2022Technology in Cancer Research & Treatment
Lapatinib and lapatinib plus trastuzumab therapy versus trastuzumab therapy for HER2 positive breast cancer patients: an updated systematic review and meta-analysis.2022Systematic Reviews
The adverse effects of trastuzumab-containing regimes as a therapy in breast cancer: a piggy-back systematic review and meta-analysis.2022PLOS ONE
Multiple Bayesian network meta-analyses to establish therapeutic algorithms for metastatic triple negative breast cancer.2022Cancer Treatment Reviews
Systemic therapy for patients with HER2-positive breast cancer and brain metastases: a systematic review and meta-analysis.2022Cancers
Pertuzumab combined with trastuzumab compared to trastuzumab in the treatment of HER2-positive breast cancer: a systematic review and meta-analysis of randomized controlled trials.2022Frontiers in Oncology
Trastuzumab combined chemotherapy for the treatment of HER2-positive advanced gastric cancer.2022Medicine
Determining the optimal (neo)adjuvant regimen for human epidermal growth factor receptor 2-positive breast cancer regarding survival outcome: a network meta-analysis.2022Frontiers in Immunology
T-DM1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: a meta-analysis.2022BMC Cancer
Comparative effectiveness and tolerability of targeted agents combined with chemotherapy in patients with HER2-positive gastroesophageal cancer: a network meta-analysis.2022Saudi Journal of Gastroenterology
Adjuvant and neoadjuvant breast cancer treatments: a systematic review of their effects on mortality.2022Cancer Treatment Reviews
Survival after neoadjuvant therapy with trastuzumab-lapatinib and chemotherapy in patients with HER2-positive early breast cancer: a meta-analysis of randomized trials.2022ESMO Open
Neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer.2022The Breast
Neoadjuvant treatment with HER2-targeted therapies in HER2-positive breast cancer: a systematic review and network meta-analysis.2022Cancers
Safety of trastuzumab deruxtecan: a meta-analysis and pharmacovigilance study.2022Journal of Clinical Pharmacy and Therapeutics
Toward a treatment sequencing strategy: a systematic review of treatment regimens in advanced gastric cancer/gastroesophageal junction adenocarcinoma.2021Oncologist
A systematic review of HER2 blockade for the curative treatment of gastroesophageal adenocarcinoma: successes achieved and opportunities ahead.2021Cancer Treatment Reviews
Treatment outcomes among human epidermal growth factor receptor 2 positive breast cancer patients: a systematic review.2021Journal of Oncology Pharmacy Practice
Efficacy and safety of anti-HER2 agents in combination with chemotherapy for metastatic HER2-positive breast cancer patient: a network meta-analysis.2021Frontiers in Oncology
Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials.2021The Lancet Oncology
Methodological quality evaluation of systematic reviews or meta-analysis of trastuzumab-based therapy for breast cancer: a systematic review.2021Medicine Open
Efficacy of second-line treatments for patients with advanced human epidermal growth factor receptor 2 positive breast cancer after trastuzumab-based treatment: a systematic review and Bayesian network analysis.2021Journal of Cancer
The efficacy and safety of additional anti-HER2-targeting drugs in the treatment of HER2-positive advanced breast cancer: a meta-analysis.2021Anticancer Agents in Medicinal Chemistry
A review of fam-trastuzumab deruxtecan-nxki in HER2-positive breast cancer. 2021Annals of Pharmacotherapy
Quality of life during palliative systemic therapy for esophagogastric cancer: systematic review and meta-analysis.2020Journal of the National Cancer Institute
Benefits of adjuvant treatment including trastuzumab in HER2-positive pT1a-bN0M0 breast cancer: a systematic review and meta-analysis.2020Annals of Translational Medicine
Evaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysis.2020Breast Cancer Research and Treatment
Lapatinib plus local radiation therapy for brain metastases from HER-2 positive breast cancer patients and role of trastuzumab: a systematic review and meta-analysis.2020Frontiers in Oncology
Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis.2020The Breast
Targeted neoadjuvant therapy in the HER-2-positive breast cancer patients: a systematic review and meta-analysis.2019Onco Targets and Therapy
Clinical efficacy of combination of pertuzumab, trastuzumab, and docetaxel for treatment of patients with HER2-positive breast cancer.2019Medicine Open

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