AstraZeneca and Daiichi Sankyo’s Trastuzumab Deruxtecan Approved in China for HER2-Positive Gastric Cancer

On August 13, the official website of China's National Medical Products Administration (NMPA) just displayed,AstraZeneca(AZN.US)(AstraZeneca) and Daiichi Sankyo's jointly developed new indication for the injectable drug Trastuzumab Deruxtecan has been approved. According to the priority review announcement by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the approved indication for this drug is: for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received two or more treatment regimens. Trastuzumab Deruxtecan is a uniquely designed HER2-targeted antibody-drug conjugate (ADC) and has already been approved in China for breast cancer indications.

Trastuzumab Deruxtecan is an ADC targeting HER2, composed of a humanized anti-HER2 monoclonal antibody linked to a topoisomerase-I inhibitor (DXd, a camptothecin derivative) through a stable cleavable tetrapeptide linker. According to publicly available information, Trastuzumab Deruxtecan was previously approved in China in February 2023 and July 2023, respectively, for the treatment of adult patients with HER2-positive breast cancer and adult patients with HER2-low breast cancer.

Editor: Wang Yongsheng