Cancer Drug Developers Get More Help in FDA’s New “Oncology Center of Excellence” 
[Posted on: Thursday, June 30, 2016]

In his State of the Union address this year, President Obama announced the “Cancer Moonshot” of the US government whereby multiple aggressive initiatives were launched to find cures for cancer. Over the last six months, numerous initiatives have been announced to encourage research, increase patient participation in clinical trials, and expedite the approval of new cancer drugs. Most new cancer drugs are eligible for the 6-month priority review and most of the breakthrough designations have been for cancer drugs. Cancer is the second leading cause to deaths in the US accounting for about 22% or 600,000 of all deaths. Cancer is also one of the most studied diseases. About 30 percent of all open clinical trials are for anti-cancer products; FDA has approved 61 new molecular entities for cancer treatment in the last 6 years. To add to the resources available to cancer drug developers, yesterday FDA announced the creation of a new “Oncology Center of Excellence” which would bring together FDA’s own cancer experts from all three major centers - drug, biologic and medical devices – to this independent center. OCE represents a reorganization of FDA’s own experts to increase efficiency. It would be lead by FDA’s leading voice for cancer product for the last 10 years. Dr Richard Pazdur. Dr. Pazdur has lead FDA’s Office of Hematology and Oncology Products (OHOP) within CDER and is well-respected by industry and regulators alike. Dr. Pazdur promised to pluck experts from various centers at the FDA to populate OCE. OCE is primarily tasked with helping develop novel combination products for cancer treatment and with developing new regulatory approaches to approve anti-cancer products. The center will likely evolve rapidly and we should see more announcements in the near future. However, for developers it may take some time to see changes. FDA’s OHOP will remain the primary contact for all oncology products but we will likely see OCE play an important role in specialized products such as combination products, companion diagnostics, precision medicine, personalized medicine, and cell-based therapies for cancer treatment. From a practical point of view, most regulatory processes for cancer products will likely remain unchanged but soon we should see senior experts at FDA get involved in novel technologies early on, not to say that it was not already happening. The Center will likely lead in developing new guidance documents for specific issues related to oncology products, and may propose increased incentives for developing certain new technologies. This is one of the many initiatives for the Cancer Moonshot, and one that is likely to be very visible since FDA will play a pivotal role in patient access to any new cancer drug. Since, it is composed of the same FDA professionals that industry has interacted with over the last 10 years or more, it should be an easier interaction between the industry and OCE; specifics to come later.