Camizestrant

iStock, leolintang Members of the FDA’s Oncologic Drugs Advisory Committee questioned the design of AstraZeneca’s Phase 3 trial of camizestrant, which involved switching treatments at the point of mutation detection, as opposed to the current practice of changing regimens upon disease progression. A panel of independent advisors have recommended against approving AstraZeneca’s oral SERD drug camizestrant for certain breast cancer patients alongside a CDK4/6 inhibitor. The issue, the panelists contended, lies with AstraZeneca’s study design. In the Phase 3 SERENA-6 trial, the pharma opted to switch patients to camizestrant or continue their current treatment schedules at the point of testing for mutations in the ESR1 gene. This is an early point to switch treatment, which usually happens upon disease progression. The committee members worried that an approval could set a precedent for other drugmakers, prompting similar trial designs without necessarily having robust evidence that an earlier switch indeed results in survival gains. “The data for changing the paradigm just isn’t there,” Stanley Lipkowitz, deputy director of the center for cancer research at the National Cancer Institute, said when explaining his ‘no’ vote. “I do agree with the FDA’s concern that all the next trials will do exactly this with no evidence that it’s improving outcomes,” he continued. While noting that he is “very excited” about oral SERDs, he couldn’t “say that we should change fundamentally how we approach patients based on this data.” “If there were an OS [overall survival] benefit, I would have voted yes,” Lipkowitz said. Adcomms Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months The FDA’s cancer advisors will discuss AstraZeneca’s application for the oral SERD camizestrant in breast cancer and the AKT inhibitor Truqap in prostate cancer. March 9, 2026 · 3 min read · Tristan Manalac Read more Six of the outside experts voted against AstraZeneca, versus three that came down in support of approval. The panelists were asked to vote on whether camizestrant demonstrated a clinically meaningful benefit in patients who have HR+/HER2- metastatic breast cancer with an ESR1 mutation. For Natalie Compagni Portis, the patient representative on the panel, her ‘no’ vote leaned more heavily on the lack of survival data, which she said could weigh heavily on the psychology of women with breast cancer. “I think it’s an exciting possibility that we could truly change the paradigm and be able to truly assure patients that treating earlier means either living better and/or living longer with metastatic breast cancer. “But I really wonder if we are exploiting the hope of women with metastatic breast cancer,” she continued. “Without evidence of longer overall survival and . . . to have very sparse data on [quality of life], it really seems only speculation and hope.” SERENA-6 showed that patients treated with the camizestrant regimen saw a 56% reduction in the risk of disease progression or death, according to data published in June 2025 in The New England Journal of Medicine . OS data remain immature. “Importantly, the panelists expressed enthusiasm for the potential of biomarker technology and did not question cami’s underlying activity, but were unconvinced by the trial meriting a change in the treatment paradigm,” Leerink Partners wrote in a Thursday evening note. “The panelists’ concerns were focused on the trial design, its endpoints, and its ability to establish clinical benefit. This leaves the door open for other cami programs.” AstraZeneca is developing camizestrant in several other treatment settings for breast cancer, including for frontline care. The FDA raised similar concerns as its outside experts. In a briefing document published earlier this week, internal reviewers pointed out that “the treatment paradigm evaluated in SERENA-6 is new.” “Currently, no drugs have FDA approval for switching treatment in patients based on detection” as opposed to at radiographic progression, the agency documents read. “It is unclear whether changing treatment at this earlier timepoint, prior to radiographic progression, results in long-term benefit.” The FDA does not have to follow the advice of an adcomm, but typically aligns with the experts’ recommendations.

Today, a brief rundown of news involving Summit Therapeutics and Esperion Therapeutics, as well as updates from Axsome Therapeutics and AstraZeneca that you may have missed.Summit Therapeutics shares fell by 27% Thursday evening on news that its cancer immunotherapy ivonescimab missed statistical significance at an interim check of a closely watched late-stage trial. Last year, Summit revealed plans to conduct an interim analysis in a particular subgroup of patients in that study, a global trial called HARMONi-3 thats testing ivonescimab and chemotherapy against Merck & Co.s Keytruda in front-line non-small cell lung cancer. Summit did so to potentially enable a faster path to regulatory approval if the results were clearly positive. On Thursday, though, Summit said ivonescimab missed that mark, and a final analysis will be conducted in the second half of the year. The disclosure amounts to a self-inflicted narrative complication leaving some investors to wonder why Summit created a situation that offered more risk than regulatory upside in the first place, wrote Stifel analyst Dara Azar.Esperion Therapeutics is being acquired by healthcare investment firm Archimed in a deal worth up to $1.1 billion. Archimed is paying $3.16 per share in cash, and could add up to $100 million more if certain sales targets are met. The acquisition ends a difficult run in the public markets for Esperion, which brought a cholesterol-lowering pill to market in 2020 but has since struggled to significantly grow sales. Shares once worth over $115 in 2015 closed at $2 on their last trading day before the Archimed deal was announced.The Food and Drug Administration has expanded use of Axsome Therapeutics' Auvelity, clearing it as a treatment for the agitation that can accompany Alzheimers disease. Auvelity was first approved four years ago for major depressive disorder and, since then, sales have steadily climbed to eventually reach $507 million in 2025. Investors were uncertain about a potential clearance in Alzheimer's agitation, though, as Axsome had reported mixed results in testing. Thursdays approval alleviated those concerns and unlocks a sizable market opportunity. In a note to clients, Mizuho SecuritiesGraig Suvannavejh estimated that around 6.5 million people with Alzheimer's in the U.S. experience some form of disease-related agitation and, given a launch price of around $15,000 per patient, Auvelity could reach peak sales of $1.2 billion in that indication in 2038. Axsome shares climbed by double digits on the news.An FDA advisory committee sided againstAstraZenecas experimental drug camizestrant in what would be a new kind of treatment setting in breast cancer. AstraZeneca is seeking an OK to administer camizestrant to patients with HR-positive HER2-negative breast cancer once an ESR1 mutation an alteration that can drive cancer growth is detected. But the majority of panelists at a Thursday meeting found the evidence supporting camizestrants benefits in that setting inconclusive, and werent convinced that the findings merited a change in the treatment paradigm, wrote Leerink Partners Andrew Berens. The FDA usually, but not always, follows the guidance of its advisory panels. AstraZeneca said in a statement that it will continue to work with the FDA during the agencys review. Regulatory filings are also still being evaluated in the Europe, Japan and elsewhere. Camizestrant is part of a new class of oral SERD medicines aiming to supplant a widely used, injectable type of hormone therapy. '