Posted by Michael Wonder on 22 May 2026
Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer
22 May 2026 - Recommendation based on SERENA-6 Phase 3 trial results which showed combination reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumour mutation.
AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been recommended for approval in the European Union for the treatment of adult patients with oestrogen receptor positive, HER2 negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.
