AstraZeneca and Daiichi Sankyo’s drug, Enhertu (trastuzumab deruxtecan), have been granted conditional approval in China as a treatment for HER2-mutant metastatic non-small cell lung cancer (NSCLC).
This approval follows the promising results from the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials, which demonstrated Enhertu’s significant clinical benefits in patients who had previously undergone treatment. Enhertu is now the first HER2-targeted therapy approved in China for this specific patient group.
The decision by China’s National Medical Products Administration (NMPA) is based on data showing Enhertu’s impressive efficacy. In the DESTINY-Lung02 trial, patients treated with Enhertu achieved a 49% confirmed objective response rate (ORR), with responses lasting an average of 16.8 months. Similarly, the DESTINY-Lung05 trial, conducted in China, reported an even higher ORR of 58.3%. This approval adds to Enhertu's growing list of approvals across multiple cancer types.
Lung cancer remains the leading cause of cancer-related deaths in China, and HER2 mutations, although rare (occurring in 2-4% of NSCLC patients), have been identified as a distinct target for treatment. Enhertu offers a new option for those affected by this aggressive form of cancer, particularly for patients whose tumors have not responded to prior therapies.
While this approval is conditional, full approval will be contingent on further confirmatory trials to validate the drug's long-term efficacy and safety. The success of Enhertu in treating HER2-mutant NSCLC marks a significant advancement in targeted cancer therapies and offers new hope for patients with limited treatment options.
This development underscores Enhertu's growing role as a transformative drug in oncology, offering treatment options in multiple cancer types.
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