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FDA Oks AstraZeneca's Enhertu To Treat Unresectable Or Metastatic HER2 Positive Breast Cancer

The U.S. Food and Drug Administration approved Daiichi Sankyo and AstraZeneca's (AZN,AZN.L) Enhertu or fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

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

The approval by the U.S. Food and Drug Administration was based on positive results from the pivotal DESTINY-Breast03 phase 3 trial that showed ENHERTU reduced the risk of disease progression or death by 72% versus trastuzumab emtansine in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity.

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