Enhertu Receives Conditional Approval for HER2-Mutant Lung Cancer in China

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China for treating adults with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) that harbors HER2 mutations. This decision by the National Medical Products Administration (NMPA) was based on positive data from the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials, showing significant objective response rates. Enhertu is the first HER2-targeted therapy for this specific cancer type in China, with full approval pending further clinical trials to confirm its benefits.

In China, over a million people are diagnosed with lung cancer each year, making up 40% of global cases, with HER2 mutations affecting about 2% to 4% of NSCLC patients. Enhertu’s approval brings a targeted treatment option for those with HER2-mutant NSCLC, a group that previously had limited treatment options. Enhertu demonstrated significant clinical responses in trials across Asia, with high objective response rates (ORR) and extended survival outcomes.

The conditional approval follows prior approvals of Enhertu for HER2-positive metastatic breast cancer and gastric cancer in China, reinforcing its broad efficacy across multiple HER2-driven tumors. AstraZeneca and Daiichi Sankyo continue to explore its potential in various cancer types globally.