China’s authorities have approved Enhertu (trastuzumab deruxtecan) as the first HER2-directed antibody-drug conjugate for patients with HER2-positive metastatic gastric cancer.
- Clinical Basis: Approval is supported by the DESTINY-Gastric04 Phase 3 trial, demonstrating survival benefits in the second-line treatment setting.
- Technical Specification: The therapy uses DXd ADC technology, linking a HER2 monoclonal antibody to topoisomerase I inhibitor payloads.
- Market Significance: This is the sixth approval for Enhertu in China over the past three years.
This summary is based on a press release issued by Daiichi Sankyo Co., Ltd.