FDA Oncology Center of Excellence Issues Annual Report
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report, including updates on regulatory reviews and initiatives, OCE programs, guidances, and more.
Regulatory Reviews
The OCE is tasked with clinical medical oncology reviews, irrespective of whether the product is a drug, device, or biologic product, and collaborates with other teams from the FDA to expedite the review of these treatments. In 2018, there were 77 oncology approvals, including 19 new molecular entities/original biologics license applications, 32 efficacy supplement/new indications, 1 efficacy supplement/new patient population, 2 efficacy supplement/accelerated approval confirmatory study, 2 biosimilars, 9 505(b)(2)s, 1 premarket approval (PMA)/new companion diagnostic, 10 PMA/modification companion diagnostic, and 1 PMA approval (combination product). Many 2018 submissions were also reviewed under expedited programs.
In the past year, the OCE created two pilot programs to improve the process of evaluating data and evidence which informs regulatory decision—the Real-Time Oncology Review and the Assessment Aid. Six products were approved using the Real-Time Oncology Review, 7 were approved using the Assessment Aid program, and 3 were approved using both programs.
Programs
Several programs from the OCE advanced their missions in 2018, including the following:
- Patient-Focused Drug Development Program (hosted a workshop for early-career patient advocates, conducted a collaboration with advocacy groups on cancer trials, published work on patient-reported outcomes analysis, hosted a workshop on standardization of patient-reported outcomes analysis methods)
- Immuno-Oncology Therapeutics Program (internal and external presentations and workshops on characterizing the safety and efficacy of immuno-oncology therapeutics and the use of novel trial designs for evaluating potential combination immuno-oncology therapies)
- Pediatric Oncology Program
- Information Exchange and Data Transformation (launched a premarket safety modernization pilot, initiated a data science fellowship program)
- Oncology Cell and Gene Therapy
- Oncology Regulatory Affairs.
Guidances
The OCE participated in the development of 11 oncology-specific guidances in 2018, covering topics including clinical trial endpoints, developing and labeling in vitro companion diagnostic devices, master protocols, expansion cohorts, radiopharmaceuticals, inclusion of adolescent patients in clinical trials, and more.
Engagement/Outreach
The OCE held 18 workshops and 16 educational symposia in 2018, and also hosted FDA-ASCO Fellows Day and the OCE Summer Scholars Program for high school students and recent graduates. Other engagement/outreach programs with significant activity in 2018 included the Scientific Liaison Program, the Disease Focus Program, Clinical Oncology for the Non-oncologist, Conversations on Cancer, and International Engagement.
2019 Goals
The OCE lists three main goals in their 2018 report for the following year.
- Project Renewal: A public health initiative being piloted by the OCE that is aiming to update safety and efficacy information for oncology product labeling.
- Project Facilitate: Establishment of a call center that would field telephone calls from physicians to assist them in helping their patients to gain easier access to unapproved therapies through the FDA’s existing Expanded Access Program.
- OCE Safety Team: A newly created OCE Safety Team will provide for consistent review, management, and communication of safety signals across development programs and throughout the pre- and postmarket life cycle of a drug.
Read and download the full report here.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
