Abstract
The FDA's new Oncology Center of Excellence is aimed at consolidating the approval processes for new cancer drugs, biologics, and devices. Richard Pazdur, MD, current director of the agency's Office of Hematology and Oncology Products within the Center for Drug Evaluation and Research will serve as the new center's acting director.
As part of Vice President Joe Biden's National Cancer Moonshot initiative, the FDA has launched the Oncology Center of Excellence (OCE) aimed at centralizing and streamlining approvals of new cancer treatments. Richard Pazdur, MD, director of the agency's Office of Hematology and Oncology Products, within the Center for Drug Evaluation and Research (CDER), will serve as its acting director and guide the new center's initial development.
The OCE consolidates what have been separate approval processes for drugs, biologics, and devices to help foster an integrated regulatory approach to reviewing novel oncology products. Pazdur will work closely with his CDER colleagues as well as the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health to get the center up and running.
“The framework of the OCE will evolve over time, so as not to disrupt the ongoing work in each center,” says Sarah Peddicord, FDA spokeswoman. “More details on the approval process will be shared once the structure is established.”
Pazdur will act as a liaison with academia, industry, and patient advocates, according to the FDA. He envisions a multidisciplinary, collaborative model for the OCE similar to the approach taken by major academic institutions and cancer centers.
“The OCE will build on [the] FDA's integrative approach to medical product development and the collaborative work that has been a hallmark of the broader FDA oncology community for nearly a decade,” says Pazdur. “By bridging the various medical product centers, the OCE will be ideally suited to support innovation and to address the recognition that multiple treatment and diagnostic options are in the best interest of patients.”
Details on how the new center will be implemented and when it will be fully up and running are still being determined, according to Peddicord. In addition, it is not yet clear how the OCE will change the approval processes for oncology products, if at all.
“Establishing a center of excellence in a disease as complex as cancer requires a thoughtful approach but, at the same time, we remain committed to the sense of urgency that is central to the Cancer Moonshot,” says Peddicord. “That's why we determined that the best way to accelerate the formation of the OCE without disrupting the ongoing work within centers would be to appoint an internal leader in an acting capacity who can focus on bringing together oncologists across the FDA.” –Janet Colwell
