PHILADELPHIA — The American Association for Cancer Research (AACR) believes that Vice President Joe Biden’s National Cancer Moonshot Initiative took an important step toward realizing its goal of increasing collaboration for the benefit of cancer patients through the U.S. Food and Drug Administration’s (FDA) announcement that it would establish an Oncology Center of Excellence (OCE). The new center is expected to expedite the development of novel combination products and support an integrated approach to tackling cancer.
“The vice president’s Cancer Moonshot Initiative is generating an extraordinary level of excitement in the cancer research community, most notably because the scientific opportunities for making major progress against the 200 diseases we call cancer are enormous at this particular time, ” said AACR President Nancy E. Davidson, MD, director of the University of Pittsburgh Cancer Institute. “However, if we are to ultimately ensure the rapid and timely approval of safe and effective treatments, it is important for the FDA to be structured and managed in a way that enables it to respond in a much more coordinated way to the needs of cancer patients, the interests and goals of cancer drug and test developers and manufacturers, and the rapidly changing scientific environment, as we have seen in the areas of companion diagnostics and next-generation sequencing (NGS) tests. Therefore, we believe this is a prudent move by the FDA to establish this new Oncology Center of Excellence.”
The new FDA OCE, which was announced at yesterday’s Cancer Moonshot Summit, will bring staff from all of the important areas of the cancer drug development process together to fuel the progress we are seeing today in preventing, detecting, and treating cancer. Davidson and AACR Chief Executive Officer Margaret Foti, PhD, MD (hc), both participated in the vice president’s Cancer Moonshot Summit.
"I was especially gratified to hear that the FDA has selected Rick Pazdur to lead this important new Oncology Center of Excellence, and we look forward to the FDA designating him as its permanent director very soon,” said Foti. “Dr. Pazdur has worked tirelessly to speed the availability of therapies for cancer patients, especially when the drugs are the first available treatment or have advantages over existing therapies. In addition, Dr. Pazdur has worked for years to build collaborative partnerships with academia, industry, other government agencies, scientific societies, and patient advocacy organizations to improve both the quality of new cancer drugs and the pace at which those drugs are delivered to patients. He also has embraced regulatory science to truly inform and improve the way in which new cancer medicines can be evaluated for their safety and efficacy.”
On an annual basis, approximately 30 percent of all new drugs approved by the FDA are oncology products, and under Pazdur’s leadership, his current office has approved many novel, innovative treatments for patients that have both extended patients’ lives and greatly improved the quality of their lives.
In 2015, Pazdur was presented with the AACR Distinguished Public Service Award for his extraordinary, steadfast leadership in scientific and regulatory affairs during his 11-year tenure as director of the FDA’s Office of Hematology and Oncology Products. Throughout his stellar career, Pazdur has made outstanding contributions to the fight against cancer, initially through his highly regarded work as a physician and researcher and now through his extraordinary dedication to improving cancer treatment via the approval of safe and effective drugs for cancer patients.