Ahmet Dirican: FDA Has Granted Two New Approvals for ENHERTU in HER2+ Early Breast Cancer
Ahmet Dirican/LinkedIn

Ahmet Dirican: FDA Has Granted Two New Approvals for ENHERTU in HER2+ Early Breast Cancer

Ahmet Dirican, Professor of Medical Oncology at Medicana International İzmir Hospital, shared a post on X:

FDA has granted two new approvals for ENHERTU (trastuzumab deruxtecan) in HER2-positive early breast cancer:

  1. Neoadjuvant setting (DESTINY-Breast11)
  2. Adjuvant treatment for residual disease (DESTINY-Breast05)

Some remarkable findings:

  • pCR rate:
    67.3% vs 56.3%
  • 53% reduction in invasive disease/recurrence events.
  • 3-year IDFS:
    92.4% vs 83.7%

ADCs are no longer limited to metastatic disease.

In HER2-positive breast cancer, they are now moving rapidly into curative-intent early-stage treatment strategies.

One of the major future questions may become: How much can T-DXd eventually replace conventional chemotherapy in selected patients?

ADCs are rapidly reshaping oncology. What once seemed achievable only in metastatic disease is now entering curative-intent settings with impressive efficacy. The HER2 story may only be the beginning.

The evolution of ADCs is accelerating faster than many expected. From late-line metastatic use to neoadjuvant and adjuvant curative strategies in just a few years. This is becoming one of the biggest paradigm shifts in modern oncology.

ADCs are no longer simply ‘targeted chemotherapy.’ With every new study, they are showing deeper responses, longer disease control, and now clear impact in early-stage curative treatment.

The future question may not be whether ADCs move earlier – but how far they can eventually replace traditional chemotherapy in selected patients.”

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