EU approves Enhertu as first tumor-agnostic HER2-directed ADC

The European Commission approved Enhertu (trastuzumab deruxtecan) on 29 June 2026 as a monotherapy for adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.¹ This marks the first tumour agnostic HER2-directed therapy and antibody drug conjugate approved in the EU for this patient population.¹

The approval followed a positive CHMP opinion and rested on a subgroup of patients with HER2-positive (IHC 3+) tumours across three Phase II trials, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.¹

In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate of 52.3% (95% CI 42.6-61.8) and median duration of response of 21.1 months (95% CI 10.6-25.0) in 111 patients with previously treated centrally or locally assessed IHC 3+ solid tumours, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumours.¹ In DESTINY-Lung01, the confirmed ORR was 52.9% (95% CI 27.8-77.0) with median DOR of 6.9 months in 17 patients with IHC 3+ non-small cell lung cancer.¹ In DESTINY-CRC02, confirmed ORR was 46.9% (95% CI 34.3-59.8) with median DOR of 5.5 months in 64 patients with IHC 3+ colorectal cancer.¹

Safety data came from a pooled analysis of patients across the three pan-tumor trials plus DESTINY-Breast01, consistent with previous trials and with no new safety concerns identified.¹

Financially, the EU approval triggers a $25 million milestone payment from AstraZeneca to Daiichi Sankyo for the tumour-agnostic indication.¹ Sales of Enhertu in most EU territories are recognised by Daiichi Sankyo.¹

Additional EU filings remain under review, including Enhertu in combination with pertuzumab for first-line HER2-positive metastatic breast cancer based on DESTINY-Breast09, and for residual invasive disease after neoadjuvant treatment based on DESTINY-Breast05.¹