The ENHERTU Type II Variation application has received validation from the European Medicines Agency (EMA) for use as a post-neoadjuvant treatment in adults with HER2 positive early breast cancer. These patients have residual invasive disease after completing neoadjuvant HER2-targeted therapy.
ENHERTU® (trastuzumab deruxtecan) targets HER2 using a DXd antibody drug conjugate (ADC) design. Daiichi Sankyo discovered the therapy and co-develops it with AstraZeneca.
The EMA confirmed that the application meets regulatory requirements. The validation starts the scientific review by the Committee for Medicinal Products for Human Use (CHMP). This step moves ENHERTU closer to potential approval in the European Union.
Why the ENHERTU Type II Variation Matters
Patients with residual invasive disease after neoadjuvant therapy face a higher risk of recurrence. Many also face progression to metastatic disease. Doctors need more effective post-neoadjuvant treatment options.
If approved, ENHERTU could offer a new standard for patients with HER2 positive early breast cancer who remain at high risk after surgery and initial therapy.
DESTINY-Breast05 Phase 3 Trial Results
The application relies on results from the Phase 3 DESTINY-Breast05 trial. Researchers presented the data at the European Society for Medical Oncology Congress (#ESMO25). They later published the findings in The New England Journal of Medicine.
In the trial, ENHERTU improved invasive disease-free survival (IDFS) compared with trastuzumab emtansine (T-DM1). The improvement reached statistical significance and showed clear clinical benefit.
The study enrolled patients with HER2 positive early breast cancer. All participants had residual invasive disease in the breast or axillary lymph nodes after neoadjuvant therapy. Investigators classified these patients as high risk for recurrence.
The primary endpoint measured investigator-assessed IDFS. Researchers defined IDFS as the time from randomization to invasive recurrence or death. Key secondary endpoints included disease-free survival, overall survival, distant recurrence-free interval, brain metastases-free interval, and safety.
Additional Regulatory Submissions in the EU
Developers continue to expand the ENHERTU program in Europe. They have submitted additional applications in the EU.
These include:
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ENHERTU plus pertuzumab as first-line treatment for unresectable or metastatic HER2 positive breast cancer, based on DESTINY-Breast09.
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ENHERTU for previously treated HER2 positive unresectable or metastatic solid tumors, supported by DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01.
These submissions aim to broaden access to ENHERTU across multiple HER2-driven cancers.
What Comes Next
The CHMP will now conduct a detailed scientific review. If the committee issues a positive opinion, the European Commission may grant approval.
The ENHERTU Type II Variation validation marks a key step for patients with HER2 positive early breast cancer in Europe. Many clinicians view this development as a potential shift in post-neoadjuvant treatment strategy.
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