What's Happening?
The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU, a HER2 directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca. This application seeks approval for the treatment of adult patients with HER2 positive unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative options. The validation marks the beginning of the scientific review process by the EMA's Committee for Medicinal Products for Human Use. The application is supported by data from three phase 2 trials, including DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01, which demonstrated clinically meaningful responses across a range of tumors.
Why It's Important?
The validation of ENHERTU's application is significant as it could lead to the first tumor agnostic indication for a HER2 directed medicine in the EU. This development could potentially expand treatment options for patients with various HER2 positive metastatic solid tumors, who currently have limited alternatives. The approval of ENHERTU could also enhance the therapeutic landscape for HER2 positive cancers, offering a new line of treatment that targets a specific protein overexpressed in aggressive cancers. This could benefit patients by providing a more targeted therapy, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.
What's Next?
Following the validation, the EMA will conduct a scientific review of the application. If approved, ENHERTU would become available for patients with HER2 positive tumors in the EU, similar to approvals in other regions. The ongoing clinical development program will continue to evaluate ENHERTU's efficacy and safety across multiple HER2 targetable cancers. The collaboration between Daiichi Sankyo and AstraZeneca will focus on further developing and commercializing ENHERTU globally, potentially expanding its use in other cancer types.
