The FDA will end a roughly nine-month hiatus of drug-related advisory committee meetings, with plans to convene its first session of 2026 to scrutinize a pair of oncology applications from AstraZeneca.
On April 30, the Oncologic Drugs Advisory Committee (ODAC) will meet to weigh AZ’s new drug application for camizestrant, an oral SERD med, and a new indication for the AKT inhibitor Truqap (capivasertib), according to a government registry (PDF).
The scheduled dual-session meeting marks the agency’s first adcomm for a drug since July, when the Psychopharmacologic Drugs Advisory Committee spurned Otsuka and Lundbeck’s bid for Rexulti in post-traumatic stress disorder. That would translate into a nine-month void barring any surprise last-minute additions.
The April 30 assembly will also be the first ODAC meeting after longtime FDA oncology czar Richard Pazdur, M.D., suddenly retired from the agency at the end of 2025, leaving cancer drug developers and the broader biopharma industry in shock.
At a time when the new administration’s FDA policies have sparked questions over regulatory consistency, the agency’s oncology division could offer a sense of continuity. Replacing Pazdur as acting director of the Oncology Center of Excellence (OCE) is division veteran R. Angelo de Claro, M.D., who began working at the FDA’s Office of Hematology and Oncology Products in 2010. He was most recently Pazdur’s second-in-command, serving briefly as deputy director of the OCE and deputy office director of the Office of Oncologic Diseases before the promotion.
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The recent absence of advisory committees has been particularly jarring, coming amid increased controversies over some of the agency’s recent decisions around rare disease therapies. From 2024 to 2025, the overall number of adcomms declined by 65%.
Speaking to reporters Thursday about the agency’s much-debated demand of a sham-controlled phase 3 trial for uniQure’s intracranial gene therapy candidate for Huntington’s disease, a senior FDA official criticized advisory committee meetings as costly, slow and “often use oomph and flash instead of scientific truth.”
The FDA advisory committee is designed to provide independent expert advice on the safety and effectiveness of products, such as drugs and vaccines, to help guide the agency’s regulatory decisions. It is also an opportunity for patients to share their experiences related to their condition and receiving an investigational treatment.
“The industry puts tremendous incentive in curating speakers” at adcomms, the official said. “There have been many papers, and, in my prior life, I published some of those papers, on the characteristics of the public speakers, who pays for them to go, the characteristics of their comments and who’s sort of controlling the public narrative.”
He also complained about how some expert panelists do not do their homework or read related information in advance.
“They often ask questions that betray [a] lack of understanding of the issue,” the FDA official said. “And they may be motivated by their own financial conflicts of interest, which the FDA has historically given many waivers for.”
Diving into AZ’s applications
As for the upcoming ODAC, the FDA will review AZ’s proposed indication of camizestrant, used in combination with a CDK4/6 inhibitor, for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer upon emergence of ESR1 mutation during first-line endocrine-based therapy.
While other oral SERD drugs have been approved in second-line ESR1-mutated HR+/HER2- breast cancer, AZ is proposing an earlier use of camizestrant before disease progression on first-line treatment has occurred.
Data from the Serena-6 study presented last year showed that AZ’s approach of adding camizestrant to patients’ first-line regimen led to a statistically significant 56% improvement in progression-free survival compared with those who stayed on first-line CDK4/6 treatment alone.
AZ also highlighted a trend in favor of camizestrant on PFS2, which measures time from randomization to progression on a second-line treatment. This could help the company argue for an earlier use of camizestrant rather than waiting for patients to progress and then get an oral SERD as a second-line therapy. But both PFS2 and overall survival data were immature at the time of the analysis, which will likely be a key discussion point for the FDA.
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Regarding Truqap, AZ is hoping to expand the drug into metastatic hormone-sensitive prostate cancer that is PTEN-deficient as part of a combination with Johnson & Johnson’s Zytiga (abiraterone).
The CAPItello-281 trial, which is likely supporting AZ’s application, met its primary endpoint of radiographic progression-free survival. But the benefit is on the borderline of being clinically meaningful, with a risk reduction of 19% and a p-value of 0.034.
Overall survival, conducted at 26% data maturity, was not mature at the interim analysis. A preliminary 10% reduction in the risk of death appears to go in favor of Truqap, but the overall survival curves recording patients’ death events between the trial’s two arms appear to merge toward the end, even as over half of the patients were still alive, suggesting uncertainty in the long-term outcome.
What’s more, Truqap’s failure in metastatic castration-resistant prostate cancer in the CAPItello-280 trial won’t boost confidence in its application in prostate cancer.
“We remain confident in the benefit of camizestrant and Truqap in these patient populations and are committed to working with the FDA to bring these options to patients in the U.S.,” an AZ spokesperson said in a statement to Fierce Pharma on Friday.
