By VETTAPHARMA reporter – Derek Roche: AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency 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. The CHMP opinion, published 22 May 2026, is based on a subgroup analysis across three Phase II trials that showed clinically meaningful responses across multiple tumour types.
The CHMP decision relied on efficacy data from DESTINY‑PanTumor02, DESTINY‑Lung01 and DESTINY‑CRC02. In DESTINY‑PanTumor02 (IHC 3+ cohort, n=111), Enhertu demonstrated a confirmed objective response rate (ORR) of 51.4% and a median duration of response (DOR) of 14.2 months in previously treated patients with centrally or locally assessed IHC 3+ solid tumours. In DESTINY‑Lung01 (centrally confirmed IHC 3+ NSCLC, n=17), the confirmed ORR was 52.9% with a median DOR of 6.9 months. In DESTINY‑CRC02 (centrally confirmed IHC 3+ colorectal cancer, n=64), Enhertu showed a confirmed ORR of 46.9% and a median DOR of 5.5 months. The company reported the safety profile was consistent with previous trials with no new safety concerns identified.
If authorised, Enhertu would become the first HER2‑directed therapy and antibody‑drug conjugate to receive a tumour‑agnostic indication in the EU, extending the drug’s label beyond established HER2 indications. Enhertu is a HER2‑directed DXd antibody‑drug conjugate discovered by Daiichi Sankyo and co‑developed and commercialised with AstraZeneca; the marketed dose cited in the trials is 5.4 mg/kg.
The regulatory move follows existing tumour‑agnostic approvals in the US and other countries based on DESTINY‑PanTumor02. AstraZeneca and Daiichi Sankyo also have additional EU submissions under review, including Enhertu in combination with pertuzumab for first‑line unresectable or metastatic HER2‑positive breast cancer (DESTINY‑Breast09) and for patients with residual invasive disease after neoadjuvant HER2‑targeted treatment (DESTINY‑Breast05).
Strategically, the CHMP opinion supports AstraZeneca’s ADC platform expansion and Daiichi Sankyo’s lead DXd programme, positioning Enhertu for broader tumour‑agnostic use and potential commercial expansion across multiple solid tumours. For patients, the recommendation signals new targeted treatment access for HER2‑overexpressing cancers where HER2 testing is not yet routine, though implementation will depend on national approvals and testing uptake.
