AstraZeneca's Etcamah wins EU approval for 1st-line ER+ breast cancer
The European Commission cleared camizestrant plus a CDK4/6 inhibitor for ER-positive, HER2-negative advanced breast cancer patients who develop an ESR1 mutation before disease progression.
AstraZeneca announced on 23 July 2026 that the European Union has approved Etcamah, known generically as camizestrant, for use alongside a CDK4/6 inhibitor. The combination, using palbociclib, ribociclib or abemaciclib, is now approved in the EU for adult patients with estrogen receptor positive, HER2-negative locally advanced or metastatic breast cancer whose tumors develop an ESR1 mutation while on first-line endocrine therapy without disease progression.1
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use and rests on results from the SERENA-6 Phase III trial, published in The New England Journal of Medicine. In a planned interim analysis, the Etcamah combination cut the risk of disease progression or death by 56 percent compared with standard care using an aromatase inhibitor plus a CDK4/6 inhibitor, based on a hazard ratio of 0.44 (95% CI: 0.31-0.60, p<0.00001), with median progression-free survival of 16.0 months versus 9.2 months.1
A later analysis added detail on secondary measures. A subsequent pre-planned analysis showed a statistically significant PFS2 benefit of 25.7 months versus 19.1 months favoring the Etcamah combination (HR: 0.63; 95% CI: 0.46-0.86; p=0.00373), while overall survival data continued to mature in the combination's favor (HR: 0.87; 95% CI: 0.57-1.30).1 The trial will continue to track overall survival as a key secondary endpoint.1
On safety, the profile of Etcamah combined with palbociclib, ribociclib or abemaciclib in SERENA-6 matched the known safety profile of each medicine, with no new safety concerns and low, similar discontinuation rates across both arms.1
Etcamah has also been approved in Japan, the United Arab Emirates and Saudi Arabia based on the same trial, and regulatory reviews are ongoing in other countries including the United States, where the FDA recently extended its Prescription Drug User Fee Act date to evaluate updated trial results.1 The company describes Etcamah as its 11th new medicine among 20 it expects to launch by 2030.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.