US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer

Review Oncology

US FDA Drug Approvals for Breast Cancer: A Decade in Review

Shaily Arora et al.

Summary: The treatment of patients with breast cancer has been greatly influenced by the approval of various drugs and indications in the past decade. This article summarizes the FDA approvals of 30 treatments for breast cancer from 2010 to 2020, including trial design, results, and regulatory considerations. The majority of approvals were for metastatic breast cancer, with a smaller number for early breast cancer. These approvals were primarily based on progression-free survival, overall survival, or objective response rate, and also involved other review initiatives and designations.

CLINICAL CANCER RESEARCH (2022)

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Article Oncology

Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue

Aileen Fernandez et al.

Summary: The current standard ERBB2 IHC assay may not be suitable for selecting patients with low ERBB2 positivity for treatment with T-DXd, as the accuracy of scoring for ERBB2 INC in the low range (0 and 1+) was poor in this study, raising the risk of misassigning patients for treatment with T-DXd.

JAMA ONCOLOGY (2022)

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Article Medicine, General & Internal

Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer

Shanu Modi et al.

Summary: Trastuzumab deruxtecan demonstrated significantly longer progression-free and overall survival compared to physician's choice chemotherapy in patients with HER2-low metastatic breast cancer.

NEW ENGLAND JOURNAL OF MEDICINE (2022)

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Review Oncology

Evolving concepts in HER2 evaluation in breast cancer: Heterogeneity, HER2-low carcinomas and beyond

Caterina Marchio et al.

Summary: HER2 is a well-known negative prognostic factor in breast cancer and its status is routinely assessed using immunohistochemistry and in situ hybridization. International recommendations have been developed by experts in the field and are continuously updated based on new experimental and clinical data.

SEMINARS IN CANCER BIOLOGY (2021)

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Article Oncology

Clinical, pathological, and PAM50 gene expression features of HER2-low breast cancer

Francesco Schettini et al.

Summary: Novel antibody-drug conjugates targeting HER2 have shown high activity in HER2-negative breast cancer with low HER2 expression, but the clinical and molecular characteristics of HER2-low breast cancer remain unclear. This study reveals that HER2-low is more common in HR-positive disease than in TNBC, and emphasizes the significant biological heterogeneity of HER2-low BC, highlighting the importance of reproducible and sensitive assays for measuring low HER2 expression.

NPJ BREAST CANCER (2021)

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Article Oncology

FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer

Preeti Narayan et al.

Summary: On December 20, 2019, FDA granted accelerated approval to ENHERTU for the treatment of HER2-positive breast cancer based on data from DESTINY-Breast01 study. The confirmed overall response rate in 184 patients was 60.3% with a median duration of response of 14.8 months. Despite the risk of interstitial lung disease, the overall safety and efficacy data supported the accelerated approval for this indication.

CLINICAL CANCER RESEARCH (2021)

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Article Oncology