Camizestrant

Dive Brief:Roches experimental drug giredestrant missed the main goal of a Phase 3 trial testing it as an initial treatment for breast cancer, the company said Monday. A combination of the therapy and Pfizers Ibrance failed to delay progression or death compared to Ibrance and hormone treatment.The data is a blow to the Swiss drugmakers ambitions for giredestrant, which is already under Food and Drug Administration review in people whose breast cancer has progressed and succeeded in staving off relapses after surgery.The trials failure will also likely reinforce doubts about the commercial potential of drugs in giredestrants class, called oral SERDs. The two approved drugs in the class, Menarinis Orserdu and Eli Lillys Inluriyo, have so far only been approved for people whose breast cancer carries a certain mutation.Dive Insight:Roche shares fell 3% in trading Monday on the Swiss exchange, following a previous drop on Friday due to disappointing data from an obesity drug.Roche has vocalized aspirations that giredestrant might become a new treatment standard for people whose breast cancer is sensitive to hormone treatment but is negative for a protein called HER2. It hasnt given up on that hope, as Roche's medical chief, Levi Garraway, said in a statement that the company remains confident in the potential of giredestrant in early and advanced disease.If the trial, called persevERA, had succeeded, giredestrant would have been the first oral SERD to help delay disease progression or death in first-line breast cancer when compared to standard of care.Inluriyo and Orserduare available for use in people whose disease has advanced after initial treatment, but neither Lilly nor Menarini have run a Phase 3 trial in the frontline setting.Jefferies analyst Michael Leuchten wrote in a note to clients Monday that the data pulls the rug from under giredestrant, calling into question whether the drug can become a multibillion-dollar seller. In addition to Mondays setback, other questions hanging over giredestrant include the fact that its trial in the post-surgical care setting didint include the CDK4/6 inhibitors in Ibrances class.Leuchten also wrote that Roche probably didnt enroll enough people in the trial to be able to show a statistically significant benefit.In addition to competing with Lilly and Menarini for market share, Roche is likely to face competition from another oral SERD, AstraZenecas camizestrant. The drugsucceeded in a first-line trial with CDK4/6 inhibitors in part because it focused on those with the ESR1 mutation, for which Orserdu and Inluriyo also target. Camizestrant is also under review by the FDA, with an advisory committee meetingscheduled for April 30.Leuchten also believes camizestrants trial in the adjuvant setting, which is due to report results next year, may be more relevant to clinical practice because it allows the use of CDK4/6 inhibitors and enrolled more patients, enabling it to potentially show a larger benefit. '

iStock, Anastasia Sudinko 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. The FDA’s Oncologic Drugs Advisory Committee will meet at the end of April to discuss two of AstraZeneca’s cancer drug applications—one seeking approval in breast cancer and another requesting a label expansion in prostate cancer. The panel of outside experts is scheduled to convene on April 30, according to a Federal Registry posting , breaking what will be more than nine months of silence for the Committee. The ODAC, as the board is more commonly known, last met in July 2025 . The April meeting will be a whole-day affair, according to the registry notice. The morning session will focus on AstraZeneca’s new drug application for the oral SERD drug camizestrant, in combination with a CDK4/6 blocker such as Pfizer’s Ibrance or Novartis’ Kisqali, for HR-positive, HER2-negative breast cancer in the first-line setting. AstraZeneca is backing its camizestrant application with data from the Phase 3 SERENA-6 study, a double-blinded and randomized Phase 3 trial comparing the oral SERD against standard of care in 315 patients. Data published in June 2025 in The New England Journal of Medicine showed that patients given the camizestrant combo saw a 56% reduction in the risk of disease progression or death versus controls, meeting the study’s primary endpoint. Camizestrant also significantly prolonged the median time to deterioration in patient-reported health status and quality of life, as compared with the standard of care. Despite acing its target outcomes, analysts at Leerink Partners expressed concerns about how SERENA-6 was designed. “Importantly, the trial does not answer if intervening earlier, leveraging serial diagnostics to detect the early emergence of [ESR1 mutations], provides a longer-term benefit to patients rather than front-loading a benefit that could have eventually occurred in a later line,” they wrote in a note to investors on Friday. In addition, while oral SERDs have become the standard of care for second-line therapy in ESR1m breast cancer patients, SERENA-6 “did not have an oral SERD widely used in the 2L and crossover to [camizestrant] was not permitted.” AstraZeneca is also testing camizestrant in SERENA-4 , another late-stage study looking to push the oral SERD class into the first-line setting in breast cancer. A readout is expected later this year, according to Leerink. During the afternoon session on April 30, the FDA’s cancer committee will discuss AstraZeneca’s bid to expand its AKT inhibitor Truqap to treat metastatic hormone-sensitive prostate cancer. Data from the Phase 3 CAPItello-281 trial showed that the drug plus abiraterone significantly improved radiographic progression-free survival versus placebo plus abiraterone. The Phase 3 CAPItello-280 study of Truqap was halted in April 2025 , however, as an independent data monitoring committee concluded that a combination regimen of the drug with docetaxel and androgen-deprivation therapy would miss its primary endpoints of overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer. FDA FDA Expert Panels Lack Balance in Pursuit of ‘Gold Standard Science’ New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion. September 8, 2025 · 6 min read · Ben Hargreaves Read more The ODAC meeting in April comes amid mounting criticism of FDA panels, which according to experts, have grown increasingly unbalanced and devoid of nuance. In a September 2025 interview with BioSpace , for instance, Diana Zuckerman, president of the nonprofit National Center for Health Research, blasted a July 2025 expert panel on the use of selective serotonin reuptake inhibitors in pregnancy, which she said put too much emphasis on the potential harms of these drugs and not enough on their benefits. “They didn’t want any nuance. It seemed they didn’t want any real difference of opinion,” she said.