Posted by Michael Wonder on 11 Sep 2025
Enhertu type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumours
11 September 2025 - Submission based on three Phase 2 trials where Daiichi Sankyo and AstraZeneca’s Enhertu showed clinically meaningful responses across a broad range of tumours.
The EMA has validated the type II variation marketing authorisation application for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive (immunohistochemistry 3+) unresectable or metastatic solid tumours who have received prior treatment and have no satisfactory alternative treatment options.
