In early 2017, the Oncology Center of Excellence (OCE) was established by the U.S. Food and Drug Administration (FDA) to modernize the cancer drug approval process by increasing intra-agency collaboration and promoting novel regulatory ideas and processes. Among critical, medical innovation initiatives, the 21st Century Cures Act (Cures) directed the agency to create inter-center institutes in major disease areas that would accelerate FDA review by increasing agency interoperability. With oncology products representing 30 percent of drugs approved by the FDA, the OCE was established as the first such inter-center institute. Led by Richard Pazdur, MD, often referred to by the media as the “Cancer Czar,” the OCE will employ an integrated approach to coordinate clinical review of oncology products while fostering an environment that supports innovation for novel regulatory ideas and processes. However, specific, sustained funding for the OCE has not been elucidated which has forestalled its ability to undertake the essential mission of translating science into new, safe and effective therapies for cancer patients.
The formation of the OCE was a necessary step for the FDA to function at its highest capabilities and provide the best available therapeutics to cancer patients in a timely manner. However, while “Cures” authorized the creation of inter-center institutes at the FDA including the OCE, specific funding for the center has not yet been appropriated. This is complicated by the fact that the center was established concurrently with the initiation of the Beau Biden Cancer Moonshot Initiative as a key partner to the NCI in the effort, so the specific source of funding is still being sorted out between Congress and the administration.
In the meantime, the FDA has allocated $3.5 million from existing resources to get the center off the ground. The AACR and other stakeholders have asked Congress to ensure that the OCE is fully funded in FY 2018. The AACR will work beyond the FY 2018 appropriations process to ensure the OCE receives the resources it needs to continue the fast pace of cutting edge research, oncology product review, and therapeutic development necessary for the millions of cancer patients nationwide.
Pazdur’s vision for the OCE includes ensuring that perspectives of patients and patient advocacy groups are considered in regulatory decision-making through such efforts as the Patient-Focused Drug Development program. Beyond simply engaging in dialogue with patients and other stakeholders, the OCE will work to advance metrics of patient experience across all aspects of development, testing, approval, and clinical use of new oncology products. Further, the OCE seeks to modernize the eligibility criteria of cancer clinical trials by enrolling patients that reflect the real-world population including allowing more older adults to enroll.
Other aims of the OCE include encouraging novel clinical trial designs such as large, simple trials that use easily measurable endpoints and common control trials that share a control arm, but may involve multiple drugs for the same indication. The discovery of early disease biomarkers has greatly increased the capability of clinicians to specifically select clinical trial participants, and has allowed for broadening of clinical trials to explore multiple populations and dosing regimens. With improved, biomarker-based patient selection and novel trial designs, the OCE is already delivering on its promise with the first FDA approval for a tissue-agnostic cancer therapeutic occurring earlier this year.
Lastly, the OCE intends to strive for “excellence” through several defined goals. The OCE will organize meetings and collaborative workshops to bring new, external voices to the regulatory process. They will prioritize communication with international regulatory agencies to foster regulatory cohesiveness and outreach beyond U.S. borders. By restructuring the oncology products review process, the OCE is expected to increase recruitment and retention of bright minds in cancer biology and related fields to the agency. To fulfill its goals and do so with excellence, the OCE must have expert human capital within the FDA.
Originally published in the AACR Cancer Policy Monitor