EU approval for Enhertu as treatment of HER2-positive metastatic breast cancer

In a second important regulatory clearance for their cancer drug in the past week, AstraZeneca (LSE: AZN) and Daiichi Sankyo’s (TYO: 4568) Enhertu (trastuzumab deruxtecan) has been granted conditional approval 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, around 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2-positive. The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.

The approval by the European Commission was based on positive results from the single-arm DESTINY-Breast01 Phase II trial, in which Enhertu showed clinically meaningful and durable antitumour activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens .It follows the December 2020 recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency, which reviewed the application under its accelerated assessment procedure.