AstraZeneca’s Camizestrant recommended for approval in EU by CHMP

The company states: “AstraZeneca’s (AZN) camizestrant in combination with a cyclin-dependent kinase 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been recommended for approval in the European Union for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during 1st-line endocrine therapy in combination with a CDK4/6 inhibitor. The Committee for Medicinal Products for Human Use – CHMP – of the European Medicines Agency based its positive opinion on the results from the pivotal SERENA-6 Phase III trial, which were presented at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine.”