FDA approves trastuzumab deruxtecan for early-stage HER2-positive breast cancer

The U.S. Food and Drug Administration has granted approval for trastuzumab deruxtecan (T‑DXd) as a treatment option in both the adjuvant and neoadjuvant settings for certain patients with early-stage HER2‑positive breast cancer.

The decision expands the drug’s use beyond its previous indication for metastatic disease, offering a targeted therapy that combines an antibody with a chemotherapy payload for patients who have undergone surgery or are preparing for it.

Approval was based on trial data showing higher pathological complete response rates and a safety profile that supports its role in lowering recurrence risk.

The new indication is expected to influence treatment guidelines and may shift market dynamics as clinicians incorporate the therapy into standard care pathways.