The FDA announced yesterday that it has established its Oncology Center of Excellence and appointed Dr. Richard Pazdur as the director. The center will help expedite the development of oncology-related medical products and encourage an integrated approach when evaluating drugs, biologics and devices for cancer treatment.

The agency believes that leveraging the expertise of regulatory scientists and reviewers will improve its ability to approve safe and effective cancer products as part of the National Cancer Moonshot Initiative. The goal of the initiative is to bring about a decade’s worth of advances in five years.

Important steps are being taken as the FDA formalizes the structure and implementation of the OCE by reorganizing its Office of Medical Products and Tobacco. The agency noted that the review criteria and application requirements for medical products as well as the work of review staff in the centers will not change.
As director of the OCE, Pazdur will lead the effort to develop and execute the integrated regulatory approach. He will also serve as acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in which he previously had the role of director.

As director of OHOP since 2005, he facilitated the coordination of oncology activities across all FDA Centers and ensured that there was collaboration between the FDA, the National Cancer Institute and other cancer-related organizations.

Under his leadership, OHOP has approved many novel treatments including the recent approval of immune checkpoint inhibitors, immune modulators and many of the targeted cancer therapies, according to the American Association for Cancer Research.

“The AACR looks forward to working with Pazdur and his staff in the months and years to come, as they have worked for years to build collaborative partnerships with academia, industry, other government agencies, scientific societies, and patient advocacy organizations to improve both the pace and the quality of new cancer drugs reaching patients,” Dr. Nancy Davidson, president of AACR, said in a statement.

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