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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