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.
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.
