Dive Brief:

• Roche said Friday that the Food and Drug Administration will decide by Dec. 18 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.  
• Roche’s submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies 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 “adjuvant” setting after surgery. 
• If approved, giredestrant would become the third new oral “SERD” on the market, following clearances for Menarini Group’s Orserdu and Eli Lilly’s Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class’ commercial outlook.

Dive Insight:

Roche executives have claimed giredestrant could “replace the standard of care” for the ER-positive, HER2-negative tumors that represent the majority of breast cancer cases.

The drug may become “the new backbone of choice” for those tumors, said Teresa Graham, chief executive of Roche’s pharmaceuticals division, on a conference call with analysts last month. Graham noted how Roche is pursuing “many combinations” involving giredestrant and other in-house medications. “Our phone keeps ringing as we are getting calls from potential partners” too, she added. 

Roche will have to overcome skepticism, though. So 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, Jefferies analyst Michael Leuchten questioned the drug’s potential to meaningfully add to Roche’s revenue growth. “Additional trials are needed, and the competition is hot on Roche's heels,” Leuchten wrote on Feb. 2.

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 “evERA” 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. 

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 — an alteration that occurs during or after exposure to hormone therapy — the relative risk was 62% lower.

Oral SERDs have so far only been approved for use in people with ESR1 mutations. If approved, giredestrant would join them. But Roche expects to submit data supporting use in the adjuvant setting “in the coming weeks” and also has a late-stage study underway in frontline breast cancer. Results from that trial are expected in the first half of 2026.