目前德曲妥珠单抗已有多个适应证在全球多个国家和地区获批上市，包括乳腺癌、肺癌、胃癌、实体瘤等。在中国，该产品此前已获批用于治疗HER2 阳性和HER2 低表达成人乳腺癌患者。此前曾多次被CDE纳入突破性治疗品种，适应症包括HER2阳性乳腺癌、HER2阳性胃或胃食管结合部腺癌、存在激活HER2突变的非小细胞肺癌等。On October 14, the official website of the China National Medical Products Administration disclosed that the injectable trastuzumab deruxtecan (Enhertu) with a new indication for lung cancer submitted by Daiichi Sankyo has been approved for marketing. Trastuzumab deruxtecan is a HER2-targeted antibody-drug conjugate developed jointly by Astrazeneca (AZN.US) and Daiichi Sankyo.
According to the Securities Times app, on October 14, the official website of the China National Medical Products Administration disclosed that the injectable trastuzumab deruxtecan (Enhertu) with a new indication for lung cancer submitted by Daiichi Sankyo has been approved for marketing. Trastuzumab deruxtecan is a HER2-targeted antibody-drug conjugate developed jointly by Astrazeneca (AZN.US) and Daiichi Sankyo.
According to the previous priority review information disclosure, this approved indication is for the treatment of inoperable or metastatic adult non-small cell lung cancer patients with HER2 activating mutations who have received at least one systemic therapy in the past. As a HER2-targeted ADC, trastuzumab deruxtecan is composed of a humanized monoclonal antibody targeting HER2 connected with a tetrapeptide cleavable linker and a topoisomerase I inhibitor (derivative of camptothecin DXd) as the effective payload.
Currently, trastuzumab deruxtecan has multiple indications approved for marketing in various countries and regions globally, including breast cancer, lung cancer, gastric cancer, solid tumors, among others. In China, the product was previously approved for the treatment of HER2-positive and HER2-low-expressing adult breast cancer patients. It has been included in breakthrough therapies by the CDE multiple times, with indications including HER2-positive breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and non-small cell lung cancer with activated HER2 mutations.
Research data on the treatment of lung cancer patients in China was announced in April 2024, showing that in previously treated HER2-mutated NSCLC patients in China, an objective response rate (ORR) of nearly 60% and a disease control rate (DCR) exceeding 91% were achieved. Overall, the DESTINY-Lung05 trial data support the use of trastuzumab deruxtecan in previously treated HER2-mutated NSCLC patients in China. The approval of trastuzumab deruxtecan in China for the treatment of lung cancer will bring new treatment options for lung cancer patients with HER2 mutations.
