{"id":92856,"date":"2026-07-29T11:05:09","date_gmt":"2026-07-29T11:05:09","guid":{"rendered":"https:\/\/www.europesays.com\/britain\/92856\/"},"modified":"2026-07-29T11:05:09","modified_gmt":"2026-07-29T11:05:09","slug":"two-breast-cancer-therapies-enhertu-and-etcamah-advance-through-eu-regulatory-process","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/britain\/92856\/","title":{"rendered":"Two breast cancer therapies, Enhertu and Etcamah, advance through EU regulatory process"},"content":{"rendered":"

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.<\/p>\n

Etcamah gains EU approval for ESR1-mutant ER-positive disease<\/p>\n

The European Commission has approved AstraZeneca\u2019s 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.<\/p>\n

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.<\/p>\n

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<\/a>. 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).<\/p>\n

\"\"<\/a><\/p>\n

Design of SERENA-6, a Phase III switch trial with camizestrant in ESR1-mutant breast cancer during first-line treatment<\/a><\/p>\n

Read a Plain language summary of publication to uncover further details of the design of the SERENA-6 clinical trial.<\/p>\n

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).<\/p>\n

Source: www.astrazeneca.com\/media-centre\/press-releases\/2026\/etcamah-approved-eu-for-er-breast-cancer.html<\/a><\/p>\n

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.<\/p>\n

If approved by the European Commission, this would represent the first new treatment option in this setting in more than a decade.<\/p>\n

The CHMP\u2019s 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<\/a>. 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.<\/p>\n

The CHMP positive opinion will now be reviewed by the European Commission, with a final regulatory decision expected in the coming months.<\/p>\n

Source: www.astrazeneca.com\/media-centre\/press-releases\/2026\/enhertu-plus-pertuzumab-recommended-for-approval-in-the-eu-by-chmp-as-1st-line-treatment-for-patients-with-her2-positive-metastatic-breast-cancer.html<\/a><\/p>\n

Click here to sign up to our dedicated breast cancer news round-up<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Two significant regulatory developments signal progress in expanding treatment options for breast cancer patients in the European Union,…\n","protected":false},"author":2,"featured_media":92857,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[20662],"tags":[11153,39567,38570,38334],"class_list":["post-92856","post","type-post","status-publish","format-standard","has-post-thumbnail","category-astrazeneca","tag-astrazeneca","tag-chmp","tag-destiny-breast09","tag-serena-6"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@UnitedKingdom\/117002942966854971","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/92856","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/comments?post=92856"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/92856\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media\/92857"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media?parent=92856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/categories?post=92856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/tags?post=92856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}