Research & Development
AstraZeneca granted US approval of Enhertu for HER2-mutant NSCLC
12 August 2022 -

Pharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) said on Friday that AstraZeneca and Daiichi Sankyo's (Tokyo:4568) Enhertu (trastuzumab deruxtecan) has been approved in the United States for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.

The accelerated approval by US Food and Drug Administration (FDA) was based on results from the DESTINY-Lung02 Phase II trial which showed a confirmed objective response rate of 57.7% in patients with HER2-mutant disease.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. It is the first approved HER2-directed therapy for patients with previously treated HER2-mutant metastatic NSCLC.



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