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.

Richard Pazdur, MD
Director, Oncology Center of Excellence

As we enter OCE’s third year, we are embarking on Project 2025, an initiative to envision the next five years in cancer drug development and leverage our resources and talents to improve collaboration with stakeholders and move the field forward as quickly as possible. I have asked our Associate Directors and staff to propose bold initiatives that reflect this spirit. Some of those projects are outlined in this report.

Two of these initiatives began in 2019.

The Project Facilitate call center opened in May 2019 to assist oncology healthcare providers or regulatory professionals in requesting access to investigational therapies for patients with cancer. Project Facilitate is a single point of contact where FDA oncology staff will help physicians and their healthcare team through the process to submit an Expanded Access request for an individual patient with cancer.

In September, we launched Project Orbis to provide a framework for concurrent submission and review of oncology products among international regulatory agencies. This collaboration may allow patients with cancer to receive earlier access to products in other countries and may benefit future drug development by encouraging greater uniformity in global standards of treatment. I traveled to Australia and Singapore to meet with the medical product regulatory agencies in both countries, as well as academic and practicing medical and hematologic oncologists, patient advocates, and industry representatives to discuss the first Project Orbis approval in conjunction with Australia’s Therapeutic Goods Administration and Health Canada.

On this visit, I also met with physicians who I knew from my days as an oncology training director, and I saw for the first time a cancer center that years earlier I had recommended be built by the Singapore government. Australia and Singapore have well-established and high-quality healthcare systems that provide leadership for clinical trials and drug development in Southeast Asia. Project Orbis may help patients with cancer in those countries get access to new therapies earlier than they would without this effort.

Key to these efforts is the underlying strong regulatory work conducted in the FDA office that reviews drugs for treatment of cancer. When I first arrived at the FDA in 1999, the agency had 10 medical oncologists who each reviewed drugs for all types of cancer. We now have more than 100 medical and hematologic oncologists who specialize in specific cancers and develop deep expertise through their review work, professional development, and research interests. Every so often, reorganization is necessary to better meet the needs of the review work. In November 2019, the Office of Hematology and Oncology Products was reorganized and renamed the Office of Oncologic Diseases. Three divisions reviewing products for oncology and hematologic malignancies became five divisions. This created a flatter organization with smaller clinical divisions to enable more efficient drug review, allow for greater stakeholder engagement in various disease programs, as well as greater professional development opportunities for staff.

At the OCE, our vision is to create a unified and collaborative scientific environment to advance the development and regulation of products for patients with cancer. We hope you will enjoy reading about the work of the OCE and that it inspires you to consider joining us on this endeavor. Take part in our public workshops, tune in to our webinars, listen to talks that our staff give at conferences around the country and the world, read our publications, follow us on Twitter, ask us questions, offer advice, and let us know what’s important to you.

Richard Pazdur, M.D.
Director, Oncology Center of Excellence