On Jun. 29, 2026, AstraZeneca and Daiichi Sankyo’s announced that Enhertu (trastuzumab deruxtecan) had been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.

The approval by the European Commission followed the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on results from a subgroup of patients with HER2-positive (IHC 3+) tumours across three Phase II trials, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.

In the DESTINY-PanTumor02 Phase II trial, Enhertu demonstrated a confirmed objective response rate (ORR) of 52.3% (95% confidence interval [CI] 42.6-61.8) and median duration of response (DOR) of 21.1 months (95% CI 10.6-25.0) in patients with previously treated centrally or locally assessed IHC 3+ solid tumours (n=111) including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumours. In DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% (95% CI 27.8-77.0) and median DOR of 6.9 months (95% CI 4.0-9.8) in patients with previously treated centrally confirmed IHC 3+ non-small cell lung cancer (NSCLC) (n=17). In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% (95% CI 34.3-59.8) and median DOR of 5.5 months (95% CI 4.2-8.1) in patients with previously treated centrally confirmed IHC 3+ colorectal cancer (n=64).

The safety profile of Enhertu was based on a pooled analysis of patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours enrolled in DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-Breast01, and was consistent with previous clinical trials, with no new safety concerns identified.

Enhertu has received a tumour agnostic indication in the US and other countries based on the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials.