The European Union has approved trastuzumab deruxtecan (Enhertu) as a single treatment for adults with advanced or metastatic HER2-positive (IHC 3+) solid tumors. The approval covers patients whose cancer has progressed after previous treatments and who have no satisfactory treatment options. Because it is a tumor-agnostic approval, the drug can be used regardless of where the cancer started in the body.
The approval was based on results from three Phase 2 clinical trials. In the DESTINY-PanTumor02 study, the drug achieved a 52.3% objective response rate, with responses lasting a median of 21.1 months. In DESTINY-Lung01, the response rate was 52.9%, while DESTINY-CRC02 reported a 46.9% response rate. Across all studies, the safety profile was consistent with previous research, with no new safety concerns identified.
The DESTINY-PanTumor02 trial enrolled adults with advanced solid tumors that had progressed after earlier treatments. Researchers evaluated tumor response as the primary goal and also measured response duration, progression-free survival, overall survival, and safety. The approval provides a new treatment option for patients with HER2-positive cancers across multiple tumor types.