Pazdur unplugged

OCE Director Richard Pazdur looks back on 25 years at FDA and forward to more progress against cancer: on The BioCentury Show

In an interview with The BioCentury Show, Richard Pazdur, director of FDA’s Oncology Center of Excellence, reflected on his 25-year tenure at the agency, discussed some of OCE’s controversial policies, and reflected on ways the cancer center’s experience could be applied more broadly across the agency.

He drew a connection between FDA’s rebuffing of marginally effective cancer drugs in the early 2000s and the surge in the development of highly effective cancer therapies over the last two decades, and suggested that other therapeutic areas could benefit from a similar tough love approach. Pazdur advocated a collaborative leadership style, cautioning senior leaders against overruling decisions made by review divisions and explaining why he declines to speak one-on-one with executives from companies with pending approval applications.

Pazdur expressed disappointment in industry’s lack of enthusiasm for pragmatic trials, arguing that they could dramatically reduce the cost and time to produce evidence to support cancer drug approvals. Anticipating concerns that regulators outside the U.S. would not accept data from pragmatic trials, Pazdur said he has received assurances from EMA and regulatory agencies in Japan and Switzerland that they are “on board” with pragmatic trials.

The OCE Director described the reasons for the agency’s requirements for greater attention to dose optimization and defended its acceptance of endpoints other than overall survival.

Pazdur said that earlier in his career he was a “complete nihilist” regarding immunotherapies, but CAR Ts and checkpoint inhibitors turned him into a believer. Looking forward, he expressed optimism that new types of immunotherapies could be as transformative as PD-1 inhibitors.