Onco-Summaries: Daily Oncology Updates at a Glance

11/09/2025

Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan has been accepted for review in the EU for HER2 +ve solid tumors (Ref)

The EMA validated the Type II Variation marketing authorization application for Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan (ENHERTU; HER2 ADC) for the treatment of adult patients with HER2 +ve, unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options.

• The application is based on data from three Phase 2 trials including DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01 where the ADC elicited clinically meaningful responses across a broad range of tumor

  
  

• Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo: “ENHERTU has shown a clinically meaningful benefit across several studies in HER2 positive metastatic solid cancers and this validation by the EMA is an important first step toward bringing this medicine to these patients in the EU. We look forward to working with the EMA to potentially secure a tumor agnostic indication for ENHERTU in the EU, similar to several other regions of the world where this approval has been received.”