ENHERTU FAM-TRASTUZUMAB DERUXTECAN-NXKI曲妥珠单抗重组冻干粉注射剂

Enhertu (Fam-trastuzumab deruxtecan-nxki) is an antibody-drug conjugate (ADC) for HER2-positive tumors, jointly developed by AstraZeneca and Daiichi Sankyo. Its mechanism of action is to deliver cytotoxic drugs into cancer cells by targeting HER2 overexpressed on the surface of tumor cells, achieving precision treatment. ‌
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Indications
‌ Breast cancer ‌: For patients with unresectable or metastatic HER2-positive breast cancer who have received two or more anti-HER2 treatment regimens in the metastatic setting. ‌
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‌ Gastric cancer ‌: For the treatment of patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. ‌
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‌ Lung cancer ‌: For patients with metastatic non-small cell lung cancer carrying HER2 mutations who have disease progression during or after platinum-based therapy. ‌
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‌ Colorectal cancer ‌: For patients with metastatic colorectal cancer carrying HER2 mutations. ‌
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Administration method
‌Dosage‌: 5.4 mg/kg, intravenous infusion once every 3 weeks (21-day cycle) until disease progression or intolerable toxicity occurs. ‌
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‌First infusion‌: It is recommended to be no less than 90 minutes; subsequent infusions can be shortened to more than 30 minutes if well tolerated. ‌
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‌Precautions‌: If infusion-related symptoms occur, the rate should be slowed down or suspended; in case of severe reactions, the drug should be permanently discontinued. ‌
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Clinical trials and efficacy
In the [DESTINY-Breast09 trial, Enhertu combined with Pertuzumab reduced the risk of disease progression or death by 44%, the median progression-free survival was 40.7 months (26.9 months in the control group), and the objective response rate was confirmed to be 85.1%. This regimen is the first breakthrough therapy in more than a decade to improve efficacy in first-line treatment regimens. ‌
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