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 China's State Drug Administration revealed that the new indications for injectable tetrastuzumab (Enhertu) lung cancer declared by Daiichi Sankyo have been approved for marketing. Destrastuzumab is an antibody-conjugated drug targeting HER2. It was jointly developed by AstraZeneca (AZN.US) and Daiichi Sankyo.
The Zhitong Finance App learned that on October 14, the official website of China's State Drug Administration revealed that the new indications for injectable detrustuzumab (Enhertu) lung cancer declared by Daiichi Sankyo have been approved for marketing. Destrastuzumab is an antibody-conjugated drug targeting HER2. It was jointly developed by AstraZeneca (AZN.US) and Daiichi Sankyo.
According to earlier priority review information, this approved indication is used to treat unresectable or metastatic adult non-small cell lung cancer patients with HER2 activation mutations and who have received at least one type of systematic treatment in the past. As a HER2-targeting ADC, detrutuzumab consists of a humanized monoclonal antibody targeting HER2 through a tetrapeptide lyzable ligand linked to a topoisomerase 1 inhibitor (camptothecin derivative DxD) payload.
Currently, detrutuzumab has been approved for marketing in many countries and regions around the world, including breast cancer, lung cancer, stomach cancer, solid tumors, etc. In China, the product has previously been approved for the treatment of HER2 positive and HER2 low expression adult breast cancer patients. CDE has been included as a breakthrough treatment many times before. Indications include HER2-positive breast cancer, HER2-positive gastric or gastroesophageal adenocarcinoma, and non-small cell lung cancer with HER2-activating mutations.
Research data on the treatment of Chinese lung cancer patients was revealed in April 2024. The study results showed that the objective response rate (ORR) of nearly 60% and the disease control rate (DCR) of over 91% were achieved in Chinese patients with HER2 mutant NSCLC previously treated. Overall, Destiny-lung05 trial data supports the use of detrastuzumab in previously treated patients with HER2 mutant nsCLC in China. Destrastuzumab has now been approved to treat lung cancer in China, which will bring new treatment options to patients with lung cancer with HER2 mutations.
