第一三共(DSNKY.US)重磅ADC新药“德曲妥珠单抗”胃癌适应症拟纳入优先审评

Core Insights - The China National Medical Products Administration (NMPA) has announced that the injection of Trastuzumab Deruxtecan (T-DXd, DS-8201a) developed by Daiichi Sankyo is proposed for priority review for treating adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received one treatment regimen [1][2] - Trastuzumab Deruxtecan is a targeted HER2 antibody-drug conjugate (ADC) that has already received approval for four indications in China, including HER2-positive advanced breast cancer and HER2 (ERBB2) activating mutation non-small cell lung cancer [1] - The DESTINY-Gastric04 study, the first Phase 3 trial for Trastuzumab Deruxtecan in HER2-positive advanced gastric cancer, demonstrated significant overall survival (OS) improvement compared to standard treatments [2] Summary by Sections Drug Approval and Indications - Trastuzumab Deruxtecan is under priority review for treating HER2-positive gastric cancer in patients who have received prior treatment [1] - The drug has previously been approved for multiple indications in China, including advanced breast cancer and non-small cell lung cancer [1] Clinical Study Results - The DESTINY-Gastric04 study showed that Trastuzumab Deruxtecan significantly improved median overall survival to 14.7 months, extending it by 3.3 months compared to the standard treatment of 11.4 months [2] - The study indicated a 30% reduction in the risk of death for patients treated with Trastuzumab Deruxtecan compared to standard therapies [2] - The safety profile of Trastuzumab Deruxtecan was deemed manageable, with low-grade adverse events, although attention is needed for the risk of interstitial lung disease [2]