Two significant regulatory developments signal progress in expanding treatment options for breast cancer patients in the European Union, with therapies targeting distinct molecular subtypes advancing through the approval process.
Etcamah gains EU approval for ESR1-mutant ER-positive disease
The European Commission has approved AstraZeneca’s Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation and without disease progression during first-line endocrine therapy, in combination with a CDK4/6 inhibitor.
Etcamah is the first and only next-generation oral SERD and complete ER antagonist approved in the first-line setting, and the only option compatible with all widely approved CDK4/6 inhibitors.
The approval follows a positive CHMP opinion and is based on the pivotal SERENA-6 Phase III trial, published in The New England Journal of Medicine. At a median follow-up of 12.6 months, the Etcamah combination yielded a median progression-free survival of 16 months (95% confidence interval [CI], 12.7 to 18.2), versus 9.2 months (95% CI, 7.2 to 9.5) in the aromatase-inhibitor group (hazard ratio for progression or death, 0.44; 95% CI, 0.31 to 0.60; P<0.0001).
Read a Plain language summary of publication to uncover further details of the design of the SERENA-6 clinical trial.
The median time until a deterioration in the patient-reported global health status and quality of life occurred was 21 months with camizestrant and 6.4 months with an aromatase inhibitor (hazard ratio, 0.54; 95% CI, 0.34 to 0.84).
Source: www.astrazeneca.com/media-centre/press-releases/2026/etcamah-approved-eu-for-er-breast-cancer.html
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
If approved by the European Commission, this would represent the first new treatment option in this setting in more than a decade.
The CHMP’s recommendation is based on results from the DESTINY-Breast09 Phase III trial, presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. The trial demonstrated that Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% compared to trastuzumab, pertuzumab, and chemotherapy (THP), with median progression-free survival exceeding 3 years.
The CHMP positive opinion will now be reviewed by the European Commission, with a final regulatory decision expected in the coming months.
Click here to sign up to our dedicated breast cancer news round-up