What's Happening?
Daiichi Sankyo, in collaboration with AstraZeneca, has announced that the European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. This validation marks the beginning of the scientific review process by the EMA's Committee for Medicinal Products for Human Use (CHMP). The application is supported by data from the DESTINY-Breast05 phase 3 trial, which demonstrated a significant improvement in invasive disease-free survival (IDFS) compared to trastuzumab emtansine (T-DM1). ENHERTU is a HER2 directed antibody drug conjugate
(ADC) and is part of Daiichi Sankyo's oncology portfolio.
Why It's Important?
The validation of ENHERTU's application by the EMA is a significant step towards providing a new treatment option for patients with HER2 positive early breast cancer, particularly those who have not achieved a complete response to neoadjuvant therapy. This development could potentially set a new standard of care in this setting, offering hope for improved outcomes in a patient population at high risk of disease recurrence. The success of ENHERTU in clinical trials underscores the potential of ADCs in oncology, highlighting the importance of targeted therapies in improving survival rates and quality of life for cancer patients. The collaboration between Daiichi Sankyo and AstraZeneca exemplifies the strategic partnerships necessary to advance innovative treatments in the competitive pharmaceutical landscape.
What's Next?
Following the validation, the EMA will conduct a scientific review of the application, which could lead to the approval of ENHERTU for use in the European Union. If approved, ENHERTU could become a new standard of care for patients with HER2 positive early breast cancer, potentially influencing treatment guidelines and practices across Europe. Additionally, Daiichi Sankyo and AstraZeneca are pursuing further regulatory submissions for ENHERTU in combination with other therapies, which could expand its use in various cancer settings. The outcome of these regulatory processes will be closely watched by stakeholders in the oncology community, as it could impact treatment paradigms and market dynamics.
