On the 19th of January, 2017, the US Food and Drug Administration (FDA) officially launched its Oncology Center of Excellence (OCE) as part of the former Vice President’s Cancer Moonshot Initiative. This exciting new development in the oncology space comes just weeks after the FDA received a letter from 28 cancer support groups calling for the reorganization of the FDA oncology portfolio and the creation of a center that will oversee all oncology products.
The OCE is intended to help accelerate patient access to new oncology treatments and devices by combining the skills and knowledge of oncology experts across the FDA’s three medical product centers: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH). In short, the main aim of this new center is to create a “cross-center” approach to reviewing oncology drugs.
Although the application requirements and review criteria for new drugs will not change, the collaboration across the FDA’s centers for drugs, biologics, and medical devices is hoped to enhance the FDA’s ability to approve safe and effective cancer products. Oncology is the first disease space to benefit from such a coordinated clinical review of products.
The FDA has appointed Richard Pazdur, the current director of the Office of Hematology and Oncology Products (OHOP), as the director of the OCE. Pazdur has been with the FDA since 1999, and has served as the director of the OHOP since its formation in 2005. He has been credited with achieving faster approval times for cancer drugs after his wife was diagnosed with ovarian cancer in 2012. Notably, the time to approval for these drugs has shrunk from an average of six months down to five months, over the past few years.
According to the FDA Commissioner, Robert Califf, Pazdur’s understanding of the inner workings of the FDA, coupled with his expertise in treating cancer, makes him the best candidate to get the OCE up and running.
The hope is that this center will serve as a model for other disease spaces, so that similar centers of excellence can be developed to help patients suffering from other indications.