FDA Oncology Center of Excellence Issues Annual Report

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The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report,1 including updates on regulatory reviews and initiatives, OCE programs, guidances, and more.

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).

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, seven were approved using the Assessment Aid program, and three were approved using both 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)
  • Immuno-Oncology Therapeutics Program (presentations and workshops on the safety and efficacy of immuno-oncology therapeutics and the use of novel trial designs to evaluate 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.

2019 Goals

The OCE report lists three main goals for 2019:

  • 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.

Download the full report at


1. U.S. Food and Drug Administration: Oncology Center of Excellence 2018 Annual Report. Available at Accessed March 29, 2019.