In his first interview after taking the reins of the FDA’s Oncology Center of Excellence (OCE), Angelo de Claro, M.D., is outlining a regulatory agenda that prioritizes organizational strength and continued regulatory modernization.
Stepping into one of the most heavyweight leadership roles in U.S. drug evaluation, de Claro faces the tall order of succeeding an FDA legend, Richard Pazdur, M.D. In his first interview, the new oncology chief vowed to build on Pazdur’s foundation while pioneering frameworks to integrate artificial intelligence into regulatory reviews, streamline drug development, and boost U.S. trial participation
De Claro rose to director of the OCE at a time when the FDA underwent another near-complete revamp of senior leadership under the Trump administration. Initially tapped as acting OCE director in late 2025, de Claro in May became the first senior FDA leader on the drug evaluation side to be confirmed in a permanent capacity during this tumultuous period.
His background as an FDA insider brings a crucial sense of regulatory stability and institutional continuity to the agency—and to an oncology master office that oversees some of the most high-stakes approvals in modern medicine. In 2025, the OCE’s work led to 17 approvals of new oncology molecules and 38 new indications for existing drugs, according to the division’s annual report published in June.
His appointment followed the departure of Pazdur, the iconic founding director of the OCE who altogether led the FDA’s oncology division for more than two decades. Under Pazdur’s tenure, the FDA created transformative review pathways and pioneered various regulatory initiatives that continue to guide the efficient and safe development of cancer drugs.
For de Claro, succeeding such a formidable figure who permanently reshaped global oncology drug development is no cakewalk. Pazdur’s departure left industry watchers, drug developers and patient advocates all eagerly monitoring how his successor would navigate the job and whether the OCE, as de Claro described in his first OCE annual report, “stands ready to meet future challenges.”
In a written interview with Fierce, de Claro expressed a sense of continuity and respect for what his predecessor built over the past two decades.
“Dr. Pazdur left a lasting legacy at the FDA by leading the Oncology Center of Excellence to where it is today,” he said. “We are using the groundwork he laid to continue to effectively execute the mission and vision of the OCE.”
De Claro is now working to refine that foundation to meet the demands of a rapidly evolving landscape.
“Priorities for the OCE are to retain and hire additional staff, deploy AI tools to aid in review, streamline oncology drug development from a regulatory standpoint and clinical trial standpoint, allow for more U.S. patients to be enrolled in clinical trials, continue external oncology community engagement as well as continue the innovation that the OCE is known for,” de Claro said.
That strive for efficiency was recently on full display during the FDA’s review of Revolution Medicines’ breakthrough pancreatic cancer drug, Rasonque (daraxonrasib). In a compressed timeline, the agency wrapped up its evaluation and granted approval more than six months ahead of the target PDUFA date, as de Claro noted in a press release last month.
The drug’s unprecedented efficacy in a notoriously difficult-to-treat cancer drew the attention of the FDA’s review team, who de Claro said, “recognized the importance of this application and were dedicated to completing the work.” The OCE utilized the real-time oncology review (RTOR) framework, which enables an earlier start to the FDA’s evaluation before the sponsor completes its application.
“In general, 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,” de Claro said, stressing the importance of upfront communication with the FDA in moving an application faster.
Rasonque’s expedited review was supported in part by the Commissioner’s National Priority Voucher (CNPV) program, an accelearted review mechanism reserved for therapies that address certain U.S. health priorities. The pilot, launched under former FDA Commissioner Marty Makary, M.D., has drawn controversy, including fears that shifting significant resources to fast-track high-profile applications like Rasonque could cause delays for other standard reviews.
Addressing that concern, de Claro assured Fierce that OCE’s CNPV reviews will not come at the expense of other review deadlines.
In the wake of a sweeping restructuring last year and the departure of veteran regulatory officials like Pazdur, de Claro pointed to ongoing recruitment efforts aimed at rebuilding and expanding review capacity.
“In the OCE and across FDA, we are prioritizing the hiring of mission-critical roles, including clinical and nonclinical review staff,” he said. “FY26 hires are building the next level of capacity and expertise, based on retirements and attrition, workload forecasts, and the skills needed to meet the FDA’s statutory public health responsibilities.”
Although de Claro has served in the FDA’s oncology division since joining the government in 2010, the industry, unnerved by a series of unconventional decisions elsewhere under Makary’s leadership team, is watching closely to see if he will chart any radical departures from established norms.
In his interview with Fierce, de Claro reinforced several key regulatory initiatives.
One of them is Project Optimus, an OCE initiative inspired by PI3K inhibitors for blood cancers and aimed at reforming the historical practice of selecting a cancer drug’s maximum tolerated dose in favor of identifying a more optimal dosing strength with a more balanced efficacy-safety profile.
As one case in point, when approving Celcuity’s Revtorpyk (gedatolisib) recently for certain breast cancer patients, the FDA required a post-marketing randomized trial to evaluate a lower dose of the PI3K inhibitor.
De Claro called the requirement “Project Optimus in action,” explaining that the agency issued it “specifically because rate of toxicities and dose interruptions signal that the optimal dose may not have been fully characterized at approval.” The trial must include patient-reported outcome assessments alongside dose- and exposure-response analyses, he stressed.
“Our dose optimization guidance is clear that sponsors should not stop at the approval,” de Claro added, “they should try to find the dose that is right for patients.”
Similarly, de Claro reaffirmed the agency’s commitment to Project FrontRunner, which Pazdur introduced about four years ago aimed at disrupting the biopharma industry’s common practice of testing and pursuing approvals for cancer meds in late-line disease settings first. A key part of the initiative involves allowing one single randomized phase 3 trial to support both an accelerated approval and the full nod.
The FDA recently approved Bristol Myers Squibb’s first-in-class CELMoD drug Zenbexus (iberdomide) in second-line multiple myeloma based on minimal residual disease (MRD)-negativity as a surrogate endpoint while the trial continues toward more mature endpoints such as progression-free survival and overall survival.
“The OCE plans to advance the Project FrontRunner initiative by having discussions with sponsors about moving clinical trials in the frontline or earlier disease setting,” de Claro said.
Project FrontRunner, Project Optimus and RTOR are just three of many regulatory initiatives established during Pazdur’s tenure. Promising to “continue the innovation that the OCE is known for,” de Claro now hopes to make his own mark.
As part of an agency-wide AI push, the OCE recently launched an AI program to advance the understanding of AI’s potential applications in oncology drug development, as well as in engaging oncology professional societies to understand where AI may affect the oncology space, de Claro noted.
The OCE director also brought up projects related to streamlining clinical trials, including reducing data collection in some areas. The Department of Health and Human Services recently rolled out Project TrialBlazer to speed up early-stage clinical development in the U.S. The program could involve less data submission to the FDA.
Project TrialBlazer arrived amid growing anxiety that the U.S. may cede its biotech leadership to China, where clinical trials often run faster and at a fraction of the cost.
“We’ve been witness to a growing share of phase 1 clinical trials moving overseas, delaying opportunities for American patients and weakening the nation’s position as a global leader in biomedical research,” Acting FDA Commissioner Kyle Diamantas said during a press call unveiling the plan. “FDA is taking action to reverse that trend.”
Consistent with previous agency messaging, De Claro said OCE “encourages more oncology clinical trial participation within the U.S. to reflect the population and to increase access for more patients within the U.S. to participate in clinical trials.”
While the OCE chief didn’t specify a bar for enrollment of U.S. patients in pivotal trials, he said the agency’s expectation is that “clinical trial data to support a marketing application reflects the intended use population within the U.S.”
Yet, despite a commitment to driving the OCE’s regulatory innovation forward, there’s one precedent de Claro isn’t ready to set just yet.
Earlier this month, the FDA granted a surprise accelerated approval to AstraZeneca’s oral SERD Etcamah (camizestrant), overruling a negative advisory committee recommendation. In a novel treatment set-up, Etcamah is allowed to be used in HR-positive, HER2-negative breast cancer upon detection of ESR1 mutation during initial first-line treatment. The approval opened a new treatment paradigm of ctDNA-guided intervention before traditional tumor progression.
However, de Claro cautioned against drawing broad conclusions, stressing that the decision “should not be interpreted as establishing molecular progression as a validated regulatory endpoint for accelerated approvals in oncology broadly.”
The endpoint in the phase 3 Serena-6 trial supporting the approval was still progression-free survival, de Claro said, “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 said. “The FDA encourages developers to engage the agency early, before designing programs that embed molecular events into the efficacy construct.”
As the biopharma sector prepares for a new era of FDA leadership, de Claro’s message made clear that the scientific knowledge that defined the OCE’s past two decades will endure. Still, whether that guiding north star will continue to shine amid broader political shifts remains to be seen. President Trump has selected Heidi Overton, M.D., Ph.D., a current White House aide, as the new FDA commissioner.