{"id":16962,"date":"2026-02-24T04:48:38","date_gmt":"2026-02-24T04:48:38","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/16962\/"},"modified":"2026-02-24T04:48:38","modified_gmt":"2026-02-24T04:48:38","slug":"roche-gets-fda-decision-date-on-closely-watched-breast-cancer-drug-2","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/16962\/","title":{"rendered":"Roche gets FDA decision date on closely watched breast cancer drug"},"content":{"rendered":"\n

This story was originally published on BioPharma Dive<\/a>. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter<\/a>. <\/p>\n

Roche said Friday that the Food and Drug Administration will decide by Dec. 18<\/a> whether to approve its experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications. <\/p>\n

Roche\u2019s submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies<\/a> at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the \u201cadjuvant\u201d setting after surgery.<\/a><\/p>\n

If approved, giredestrant would become the third new oral \u201cSERD\u201d on the market, following clearances for Menarini Group\u2019s Orserdu and Eli Lilly\u2019s Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class\u2019 commercial outlook.<\/p>\n

Roche executives have claimed giredestrant could \u201creplace the standard of care\u201d for the ER-positive, HER2-negative tumors that represent the majority of breast cancer cases.<\/p>\n

The drug may become \u201cthe new backbone of choice\u201d for those tumors, said Teresa Graham, chief executive of Roche\u2019s pharmaceuticals division, on a conference call with analysts<\/a> last month. Graham noted how Roche is pursuing \u201cmany combinations\u201d involving giredestrant and other in-house medications. \u201cOur phone keeps ringing as we are getting calls from potential partners\u201d too, she added.<\/p>\n

Roche will have to overcome skepticism, though.\u00a0So far, oral SERDs like giredestrant have largely only proven helpful for a particular subset of patients with advanced disease, limiting their sales potential. In a research note earlier this month, for instance,\u00a0Jefferies analyst Michael Leuchten questioned the drug\u2019s potential to meaningfully add to Roche\u2019s revenue growth. \u201cAdditional trials are needed, and the competition is hot on Roche’s heels,\u201d Leuchten wrote on Feb. 2.<\/p>\n

Roche, for its part, has hinted that giredestrant might be more broadly beneficial than its peers. One of its pieces of evidence came from the \u201cevERA\u201d trial now supporting its approval submission. The people enrolled in that study had already seen their ER-positive breast cancer progress after receiving hormone therapy and so-called CDK 4\/6 inhibitors.<\/p>\n

Roche enrolled a total of 373 people and randomized them to take an older drug called everolimus alongside either giredestrant or traditional hormone therapy. Those who got giredestrant had a 44% lower relative risk of dying or having their disease progress. Among people with mutations to a gene called ESR1 \u2014\u00a0an alteration that occurs during or after exposure to hormone therapy \u2014 the relative risk was 62% lower.<\/p>\n

Oral SERDs have so far only been approved for use in people with ESR1 mutations.\u00a0If approved, giredestrant would join them. But Roche expects to submit data supporting use in the adjuvant setting \u201cin the coming weeks\u201d and also has a late-stage study underway in frontline breast cancer. Results from that trial are expected in the first half of 2026.<\/p>\n","protected":false},"excerpt":{"rendered":"This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free…\n","protected":false},"author":2,"featured_media":16963,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[124],"tags":[11766,207,11767,11769,11768,134,2050],"class_list":{"0":"post-16962","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-roche","8":"tag-advanced-breast-cancer","9":"tag-breast-cancer","10":"tag-food-and-drug-administration","11":"tag-hormone-therapies","12":"tag-hormone-therapy","13":"tag-roche","14":"tag-teresa-graham"},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/16962","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=16962"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/16962\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/16963"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=16962"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=16962"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=16962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}