(CercleFinance.com) – AstraZeneca announces that its Enhertu, co-developed with Daiichi Sankyo, has been recommended by the CHMP for approval in the EU as monotherapy for the treatment of adult patients with a form of breast cancer.
This favorable opinion concerns patients with low HER2-low, unresectable or metastatic breast cancer, who have already received chemotherapy or developed a recurrence during or within six months of the end of adjuvant chemotherapy.
The CHMP based its positive opinion on the results of the phase III DESTINY-Breast04 trial, published in NEJM, which demonstrated a significant benefit in terms of survival compared to chemotherapy in this patient population.
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