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Daiichi Sankyo Announces Approval of ENHERTU® in Japan

Thursday, August 24, 2023

Daiichi Sankyo has received approval for the use of ENHERTU® (trastuzumab deruxtecan) in the treatment of adult patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) mutations and have experienced disease progression after undergoing chemotherapy.

ENHERTU is a targeted antibody-drug conjugate (ADC) designed to address HER2-positive cancers. It consists of a monoclonal antibody specific to HER2 that is linked to a topoisomerase I inhibitor, an exatecan derivative, through a stable tetrapeptide-based cleavable linker. This combination allows for targeted delivery of the drug to cancer cells expressing HER2.

The approval for ENHERTU's use in NSCLC in Japan is based on data from the DESTINY-Lung02 phase 2 trial. The interim analysis of this trial focused on patients with previously treated HER2 mutant NSCLC. The results demonstrated that ENHERTU, administered at a dose of 5.4 mg/kg, achieved a confirmed objective response rate (ORR) of 53.8% in patients with unresectable advanced or recurrent NSCLC harbouring activating HER2 mutations.

ENHERTU has previously received approvals in over 50 countries for the treatment of adult patients with HER2-positive metastatic breast cancer who have previously been treated with at least one anti-HER2 regimen and have experienced disease recurrence within six months of completing therapy. This approval was based on data from the DESTINY-Breast03 trial.

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