The European Medicines Agency’s CHMP has recommended approval of Enhertu for adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors lacking satisfactory treatment options. If approved by the European Commission, it would become the first HER2-targeted tumor-agnostic antibody-drug conjugate available in the European Union.
The recommendation is supported by phase 2 trials showing strong activity across multiple cancer types. In the DESTINY-PanTumor02 study, the confirmed objective response rate reached 51.4%, with particularly high responses in endometrial cancer. Additional trials in non–small cell lung cancer and colorectal cancer reported response rates of 52.9% and 46.9%, respectively.
The drug’s safety profile remained consistent across studies. Common serious side effects included neutropenia, anemia, fatigue, and thrombocytopenia. Interstitial lung disease and pneumonitis remained important but generally manageable risks.