First Astellas/AZN.US "T-DM1" approved in China

On October 14, the National Medical Products Administration's website showed that the new indication for intravenous trastuzumab deruxtecan (Enhertu, UHercules) for lung cancer submitted by Daiichi Sankyo has been approved for marketing. Trastuzumab deruxtecan is an antibody-drug conjugate targeting HER2, developed by AstraZeneca (AZN.US) and Daiichi Sankyo.

According to the early priority review information, the approved indication is used for the treatment of adult non-small cell lung cancer patients with HER2 activating mutations who have received at least one systemic therapy. As a HER2-targeting ADC, trastuzumab deruxtecan is composed of a humanized monoclonal antibody targeting HER2 and a payload (DXd, a taxane derivative) through a four-peptide cleavable linker.

Trastuzumab deruxtecan has already been approved for multiple indications in many countries and regions around the world, including breast cancer, lung cancer, gastric cancer, and solid tumors. In China, the product has previously been approved for the treatment of HER2-positive and HER2-low-expressing adult breast cancer patients. It has been included in breakthrough therapy designations by the Center for Drug Evaluation (CDE) multiple times, including HER2-positive breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and non-small cell lung cancer with activating HER2 mutations.

The data for Chinese lung cancer patients were revealed in April 2024, showing an objective response rate (ORR) of nearly 60% and a disease control rate (DCR) of over 91% in previously treated HER2-mutated NSCLC Chinese patients. Overall, the DESTINY-Lung05 trial data support the use of trastuzumab deruxtecan for previously treated HER2-mutated NSCLC Chinese patients. The approval of trastuzumab deruxtecan for the treatment of lung cancer in China will provide new treatment options for HER2-mutated lung cancer patients.