AstraZeneca and Daiichi Sankyo announced that the European Commission has approved Enhertu (trastuzumab deruxtecan) as a monotherapy for adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior treatment and have no satisfactory treatment options.
This landmark milestone establishes Enhertu as the first-ever tumour-agnostic HER2-directed therapy and antibody-drug conjugate (ADC) approved in the European Union (EU). The approval transitions precision oncology forward by allowing clinicians to treat patients based on the specific HER2 biomarker, regardless of where the cancer originated in the body.
The EC approval is based on clinically meaningful, durable efficacy data demonstrated across a subgroup of patients in three Phase II trials;DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. In the pan-tumour trial, Enhertu achieved a confirmed objective response rate (ORR) of 52.3% and a median duration of response (DOR) of 21.1 months across various aggressive cancers, including biliary tract, bladder, cervical, endometrial, and ovarian tumours.
With this approvalmarking Enhertu’s sixth indication in the EU,a $25 million milestone payment is due from AstraZeneca to Daiichi Sankyo.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
