EMA recommends extension of therapeutic indications for trastuzumab deruxtecan
esmo - New indication concerns monotherapy in the adjuvant treatment for adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment
AI Summary: The EMA has recommended expanding therapeutic indications for trastuzumab deruxtecan (Enhertu), updating its EPAR to reflect new evidence supporting wider clinical use across additional HER2‑expressing tumours. Regulators’ endorsement could increase patient access while clinicians watch for ADC class toxicities and await implementation details from national authorities.
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