FDA approves Enhertu for two new breast cancer indications

Enhertu has been approved by the U.S. FDA for two new breast cancer indications in the neoadjuvant and adjuvant settings of patients with HER2 positive early breast cancer. In the neoadjuvant setting, Enhertu followed by a taxane, trastuzumab and pertuzumab has been approved for the treatment of adult patients with HER2 positive stage 2 or stage 3 breast cancer. In the adjuvant setting, Enhertu has been approved for the treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab and taxane-based treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo (DSNKY) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (AZN).