Trastuzumab Deruxtecan First Approval for HER2-Mutant Non–Small Cell Lung Cancer

The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd) (Enhertu®, Daiichi Sankyo Inc.) for treatment of adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) mutations. This approval is specific to individuals who have undergone previous systemic therapy. Trastuzumab deruxtecan is the first drug to be approved for treatment of HER2-mutant NSCLC. "HER2 mutations are an established molecul...

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Trastuzumab Deruxtecan Approved for Treatment of HER2-Low Breast Cancer

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–low breast cancer. This treatment is indicated for patients who have previously undergone chemotherapy in the metastatic setting or who developed disease recurrence during or within six months of completing adjuvant chemotherapy. "Currently available HER2-directed therapies have not improved clinical outcomes in p...

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Fam-Trastuzumab Deruxtecan-nxki Approved for Treatment of Breast Cancer

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo, Inc.) for treatment of patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer. The approval is specific to individuals who have had prior treatment with an anti–HER2-based regimen in the metastatic, neoadjuvant, or adjuvant setting and have developed disease recurrence within six months of completing therapy. "Although HER2-targeted therapies have improved dise...

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Fam-Trastuzumab Deruxtecan-Nxki Approved for Advanced Gastric Cancer

The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo) for the treatment of adult patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal adenocarcinoma previously treated with a trastuzumab-based regimen. Approval was based on DESTINY-Gastric01 (NCT03329690), a multicenter, open-label, randomized trial. For this study, led by study author Kohei Shitara, MD, Chief of the Department of Gastrointestinal ...

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Advanced Gastric Cancer: [Fam-] Trastuzumab Deruxtecan Shows Promise

A phase 1 clinical trial reports that [fam-] trastuzumab deruxtecan shows preliminary activity in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction cancer. "These results are encouraging given the limited options for patients with advanced HER2-positive gastric cancer that progresses after initial treatment regimens including trastuzumab," commented Kohei Shitara, MD, Chief of the Department of Experimental Therapeutic...

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[Fam-] Trastuzumab Deruxtecan in Advanced Gastric Cancer With Kohei Shitara, MD

Current treatment options are highly limited for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction cancer, particularly after trastuzumab. A potential new treatment has emerged in a phase 1 clinical trial, which reports that [fam-] trastuzumab deruxtecan shows preliminary activity in patients with heavily pretreated HER2-positive gastric or gastro-esophageal junction cancer. In this interview with i3 Health, Kohei Shitara, MD, l...

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New FDA Approval for Relapsed/Refractory HER2-Positive Metastatic Breast Cancer

​The FDA has now granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo) for patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer previously treated with at least two anti-HER2–based regimens in the metastatic setting. Fam-trastuzumab deruxtecan-nxki, otherwise known as trastuzumab deruxtecan, is an antibody-drug conjugate consisting of an anti-HER2 antibody, a cleavable tetrapeptide-based linker, and a...

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