Enhertu approved in China as first HER2-directed therapy for NSCLC

UK pharma major AstraZeneca (LSE: AZN) and Japanese drugmaker Daiichi Sankyo’s (TYO: 4568) Enhertu (trastuzumab deruxtecan) has won conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.

The companies noted that the conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials. Full approval for this indication will depend on the clinical benefit of a confirmatory trial.

Each year in China, more than one million people are diagnosed with lung cancer, accounting for more than 40% of the world’s lung cancer patients – the majority are diagnosed with advanced disease. Around 2% to 4% of patients with NSCLC have tumors with activating HER2 mutations.