Recommendation based on positive results from the DESTINY-Breast01 trial, which showed durable responses in patients with previously treated disease AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s trastuzumab deruxtecan has been recommended for conditional marketing authorisation in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. In Europe, approximately 520,000 cases of breast cancer in women are diagnosed annually, with roughly one in five cases being HER2 positive. 1-2 The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year.