AstraZeneca: EMA validates Enhertu application

(CercleFinance.com) - Japan's Daiichi Sankyo announced on Monday that the European Medicines Agency (EMA) had validated the type II variation application filed for Enhertu, the antibody it is developing with AstraZeneca, in the treatment of an advanced form of breast cancer.


The European regulatory authority's opinion concerns the use of Enhertu as monotherapy in patients with inoperable or metastatic breast cancer with low 'HER2' expression who have already received endocrine therapy.

The company states that its opinion is based on Phase 3 clinical results showing a statistically significant and clinically meaningful improvement in progression-free survival in treated individuals compared to standard chemotherapy.

Enhertu is an antibody-drug conjugate specifically designed to target HER2, developed and marketed jointly by Daiichi Sankyo and AstraZeneca.


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