Contributor spotlight: FDA Oncology Center of Excellence

After five years of tremendous growth since its formation in 2017, the Oncology Center of Excellence slowed the launch of new projects in 2022 to allow existing projects to grow in depth and strength.

This year, our work examined several ways the OCE could leverage its resources to modernize evidence generation in oncology drug development. That is, what could the OCE do to encourage the development of clinical trial data that responds to the modern needs of patients and their physicians.

In January 2022, the Oncology Center of Excellence marked its fifth anniversary by looking back at what we accomplished and looking ahead to further progress toward achieving our vision to create a collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer.

Since its formation in 2017, the OCE has established more than 30 outward-facing programs and projects to educate, inform, conduct research, and collaborate. The OCE is committed to driving change in cancer drug development that results in more efficient and accessible clinical trials, more effective and safer medical products, and better outcomes for patients with cancer. This begins with rigorous medical product review for efficacy and safety, but also stepping back to look at what’s happening across the field of oncology and determining how the OCE can leverage its expertise.

As the Oncology Center for Excellence (OCE) marked its third anniversary one year ago, in January 2020, the COVID-19 pandemic began, causing world-wide upheaval in our society and the medical community. Since then, the FDA has focused tremendous effort on addressing the COVID-19 population, and rightly so. Here at the OCE, our attention has been devoted to patients with cancer to make sure they were not forgotten during this pandemic.

Our work has continued without interruption and with renewed energy to face the challenges of patients with cancer during this period of upheaval. The OCE participated in writing a guidance emphasizing the flexibility the FDA would exercise with regard to conduct of clinical trials with decentralized trial procedures aimed at patient safety. Patients often cannot go back to major cancer centers, and some of the testing and doctor visits can be conducted in communities nearer to patients’ homes, so the guidance allows for that. The OCE went on to issue over a dozen guidances in 2020 on many aspects of oncology drug development.

This past year marked my 40th year as an oncologist and 20th year at the Food and Drug Administration. When I started out in oncology, there were about 30 approved drugs for treating patients with cancer. 

In the past 20 years, we approved 150 drugs for oncology and hematologic malignancies. But the major advances have occurred in our understanding of the mechanisms of disease. That has led to targeted therapies aimed at specific molecular targets on the cancer cells, as well as a greater understanding of the tumor and immunology of disease. We have a whole new class of drugs, the PD-1 drugs, as well as CAR-T therapies. Although the new therapies offer potentially better outcomes for patients, it is also clear to me that improvements can be made in the development of the next generation of these therapies to encourage collaboration among drug developers, reduce duplicative efforts, and enroll patients wisely on trials that will make a difference.

The FDA Oncology Center of Excellence, authorized by the 21st Century Cures Act, was established in January 2017 to help facilitate the development and clinical review of anti-cancer therapies by uniting scientific experts across the Agency’s product centers to conduct expedited review of drugs, biologics, and devices.

In the two years since its formation, the OCE has collaborated with FDA’s medical product centers to expedite many important clinical reviews, including the first two chimeric antigen receptor T-cell therapies for the treatment of advanced hematologic malignancies, and the first approvals of site-agnostic indications. The OCE also created two pilot programs to improve the process of evaluating data and evidence to generate a benefit-risk assessment which informs regulatory decisions: the Real-Time Oncology Review and the Assessment Aid. Our experts have led the development of 12 guidance documents on important aspects of oncology and malignant hematology product development.

Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers.

The FDA is taking important steps to formalize the structure and implementation of the OCE as part of its overarching effort to better address the needs of cancer patients, through reorganization within the FDA’s Office of Medical Products and Tobacco.