Etcamah approved in EU for first-line advanced ER-positive breast cancer

The European Commission has granted marketing authorisation for Etcamah (camizestrant) as a first-line treatment for postmenopausal women with advanced or metastatic oestrogen receptor-positive (ER+), HER2-negative breast cancer with an emergent ESR1 mutation. The drug is to be used in combination with a CDK4/6 inhibitor.

This approval provides a new therapeutic option targeting patients with ESR1 mutations in advanced disease. The Phase III results from the SERENA-6 trial demonstrated that Etcamah combined with a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% compared to placebo in patients with an emergent ESR1 tumour mutation.

Etcamah is positioned as the first and only next-generation oral SERD (selective oestrogen receptor degrader) and complete ER antagonist approved for first-line use and as an option in combination with all widely approved CDK4/6 inhibitors. This offers a more tailored and flexible approach to initiating treatment.

This marks the eleventh new medicine from AstraZeneca expected to launch among the twenty anticipated by 2030. The pharmaceutical company continues its focus on cancer research and the development of novel therapies.