AstraZeneca: Enhertu recommended for approval in EU

(CercleFinance.com) - Enhertu, a new drug developed by AstraZeneca in collaboration with Japan's Daiichi Sankyo, has been recommended for use in Europe by the Committee for Medicinal Products for Human Use (CHMP), both groups announced on Friday.


The CHMP's decision should pave the way for future approval of this conjugated antibody as a monotherapy treatment for patients with HER2-low or ultra-low metastatic breast cancer.

It is intended for individuals who have already received at least one endocrine therapy and are ineligible for further endocrine therapy.

A Phase 3 clinical trial showed that Enhertu reduced the risk of death or disease progression by 38% compared with chemotherapy.

Median progression-free survival reached 13.2 months, compared with 8.1 months in the chemotherapy arm.


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