Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) and Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Tuesday that Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer.

This approval expands Enhertu's use to an earlier treatment setting for patients who have progressed on one or more endocrine therapies.

The approval was based on the DESTINY-Breast06 Phase III trial, which demonstrated Enhertu's superiority over chemotherapy in terms of progression-free survival.

Enhertu is an antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised by the two companies.

Daiichi Sankyo will recognise sales of Enhertu in the United States, while AstraZeneca will report its share of gross profit margin as Alliance Revenue.

AstraZeneca will make a USD175m milestone payment to Daiichi Sankyo following this approval.

Regulatory applications for this indication are under review in the European Union, Japan and several other countries.