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AstraZeneca : Enhertu Recommended For Approval In EU By CHMP For Metastatic Breast Cancer

AstraZeneca Plc (AZN.L,AZN) and Daiichi Sankyo's Enhertu or trastuzumab deruxtecan has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use (CHMP) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

The recommendation was based on DESTINY-Breast03 trial results showing the companies' Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1).

The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

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