FDA Oncology Chief to Focus on AI, Streamlined Drug Development
Oncology Center of Excellence (OCE) director Angelo de Claro says the center will build on initiatives established under longtime and former OCE chief Richard Pazdur while using artificial intelligence (AI) and other approaches to streamline cancer-drug development and increase U.S. participation in clinical trials. Pazdur spent decades overseeing cancer drug approvals at FDA until he retired 12/2025 due to management tensions shortly after accepting the position as CDER director.
In his first interview since taking over OCE, de Claro tells Fierce Pharma that office priorities include hiring and retaining staff, deploying AI tools to assist regulatory review, streamlining drug and clinical-trial development, increasing U.S. enrollment in oncology trials and continuing the center’s regulatory innovation.
As part of an agency-wide AI push, OCE recently launched an AI program to advance the understanding of AI’s potential applications in oncology drug development, as well as engaging oncology professional societies to understand where AI may affect the oncology space, de Claro says.
Regarding more efficient reviews, de Claro points to the recent approval of Revolution Medicines’ Rasonque (daraxonrasib) for pancreatic cancer as an example of OCE’s efforts to accelerate approvals. FDA approved the drug more than six months ahead of its target user fee date, using the real-time oncology review program, which allows the agency to begin evaluating portions of an application before a sponsor has completed its full submission. “When topline results are received during early clinical trials, the OCE may proactively start working with a company to ensure that their application meets our review needs,” he says.
de Claro also reaffirmed OCE’s commitment to Project Optimus, which seeks to move oncology drug development away from selecting a maximum tolerated dose toward identifying doses that provide a better balance of efficacy and toxicity. He cites FDA’s recent approval of Celcuity’s Revtorpyk (gedatolisib), which included a requirement for a postmarketing randomized trial evaluating a lower dose.
de Claro notes that toxicity and dose interruptions suggested that the optimal dose had not been fully characterized. “Our dose optimization guidance is clear that sponsors should not stop at the approval,” he said. “They should try to find the dose that is right for patients.”
Staffing remains a priority following retirements, attrition and broader changes at FDA. de Claro says the agency is prioritizing clinical and nonclinical review positions to rebuild capacity and expertise.
De Claro says OCE also wants more oncology trial participation in the U.S. to improve patient access and ensure that clinical-trial populations reflect the patients for whom therapies ultimately will be used. He did not specify a fixed U.S. enrollment threshold, saying expectations will vary by indication and patient population.
De Claro also cautions against interpreting FDA’s recent accelerated approval of AstraZeneca’s Etcamah (camizestrant) as establishing molecular progression as a broadly validated endpoint for accelerated oncology approvals. The endpoint in the Phase 3 Serena-6 trial supporting the approval was still progression-free survival, de Claro notes, “albeit from a novel starting point — the time of detection of ESR1, which is a well-characterized resistance biomarker.”
“We are open to novel diagnostic-driven trial designs, but the evidentiary bar must be met,” he asserts. “The FDA encourages developers to engage the agency early, before designing programs that embed molecular events into the efficacy construct.”