The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee will meet on April 30 to review two of AstraZeneca’s cancer drug applications, one for breast cancer and another for prostate cancer, according to a Mar. 9 announcement.
This meeting marks the first time in more than nine months that the committee will convene, with its last session held in July 2025. The upcoming meeting is significant as it will address key questions about new treatments for serious cancers and comes amid ongoing debate over the balance and approach of FDA expert panels.
The morning session will focus on AstraZeneca’s application for camizestrant, an oral selective estrogen receptor degrader (SERD), used in combination with a CDK4/6 inhibitor such as Pfizer’s Ibrance or Novartis’ Kisqali, for hormone receptor-positive, HER2-negative breast cancer in the first-line setting. The company supports its application with data from the Phase 3 SERENA-6 study involving 315 patients. Results published in June 2025 showed that patients receiving camizestrant experienced a 56% reduction in risk of disease progression or death compared to those on standard care, achieving the study's primary endpoint. Camizestrant also extended the median time before deterioration in patient-reported health status and quality of life.
However, analysts at Leerink Partners raised concerns about the design of SERENA-6. “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. They also noted that while oral SERDs are now standard second-line therapy for ESR1m breast cancer patients, SERENA-6 did not include an oral SERD widely used in this setting and did not allow crossover to camizestrant.
AstraZeneca is conducting another late-stage trial called SERENA-4 to further evaluate camizestrant as a first-line treatment for breast cancer, with results expected later this year according to Leerink.
In the afternoon session, the committee will discuss expanding AstraZeneca’s AKT inhibitor Truqap for metastatic hormone-sensitive prostate cancer based on positive results from the Phase 3 CAPItello-281 trial. However, another study—CAPItello-280—was halted after an independent monitoring committee determined it would not meet its main goals regarding overall survival and progression-free survival.
The timing of this ODAC meeting comes as FDA expert panels face criticism over their composition and decision-making processes. Diana Zuckerman, president of the National Center for Health Research, commented on recent panel discussions: “They didn’t want any nuance. It seemed they didn’t want any real difference of opinion,” she said.
