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News
Europe's drug advisory committee has recommended approving T-DXd (Enhertu) as adjuvant therapy for HER2-positive early breast cancer patients with residual disease after neoadjuvant treatment. Data from the phase 3 DESTINY-Breast05 trial showed T-DXd reduced the risk of invasive disease recurrence or death by 53% compared to the current standard of care, T-DM1. The drug is already approved in the US for the same indication.
Europe's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of fam-trastuzumab deruxtecan (T-DXd; Enhertu) for adjuvant treatment of HER2-positive early breast cancer patients who have residual invasive disease after neoadjuvant therapy. The recommendation is backed by data from the phase 3 DESTINY-Breast05 trial, published in the New England Journal of Medicine and presented at the 2025 ESMO Congress.
In the trial, T-DXd slashed the risk of invasive disease recurrence or death by 53% compared to T-DM1 (Kadcyla), the current adjuvant standard of care. The benefit was consistent across all patient subgroups, and fewer central nervous system recurrences were observed with T-DXd. T-DXd is already approved in the US for this same indication.
By the Numbers:
72% of patients in both arms completed all 14 planned treatment cycles
Why it matters: For HER2-positive breast cancer patients who still have residual disease after neoadjuvant therapy — a group at substantially higher recurrence risk — T-DXd could redefine post-surgery care in the EU, offering a more effective path toward long-term disease-free survival and potential cure.
