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:
The OCE report lists three main goals for 2019:
Download the full report at www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm633798.htm. ■
1. U.S. Food and Drug Administration: Oncology Center of Excellence 2018 Annual Report. Available at www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/UCM634010.pdf. Accessed March 29, 2019.