Regulatory Focus™ > News Articles > 2021 > 2 > OCE year 4: Progress despite a pandemic

OCE year 4: Progress despite a pandemic

Posted 08 February 2021 | By Jeff Craven 

OCE year 4: Progress despite a pandemic

Richard Pazdur, MD

Last year, the Oncology Center for Excellence laid out their vision for the future in the Project 2025 initiative, an ambitious effort to outline the future of cancer drug development and collaborate with stakeholders advance the field of oncology.
While the organization remains committed to Project 2025, they acknowledged efforts in 2020 soon shifted to address the needs of patients with cancer during the COVID-19 pandemic, according to Richard Pazdur, MD, director of the US Food & Drug Administration (FDA) Oncology Center of Excellence (OCE).
“Here at the OCE, our attention has been devoted to patients with cancer to make sure they were not forgotten during this pandemic,” Pazdur said in a director’s message prefacing the OCE’s 2020 annual report.
OCE continued to write guidances in 2020 in areas in oncology and malignant hematology, Pazdur said, but also contributed to guidance released in March of 2020 that sought to minimize the risks for patients involved with clinical trials; this guidance delineated flexibility FDA would permit in conducting those trials to safeguard patients, including using decentralized trial formats. “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,” he explained.
But despite the pandemic, “the work never stopped from a regulatory standpoint,” Pazdur said. Of the 40 new indications and 19 new molecular entities (NMEs) approved in 2020, a number of approvals were “subcutaneous dosing formulations, increasing dosing intervals, and oral formulations of already approved drugs” to help reduce patient exposure to COVID-19 through in-person visits to receive cancer therapies.            
During the first year of Project Orbis, the global review program received 60 oncology marketing applications between June 2019 and June 2020, OCE said. Of these applications, there were 38 approvals, with NMEs comprising 28% of those approvals. OCE noted the project was started due to a lag of months or years after applications had been filed in the US. Data from the first year showed a 0.6-month time gap between an FDA submission and an application being submitted through Project Orbis, with a median time-to-approval of 4.2 months within the FDA compared with 4.4 months under Project Orbis partners (POP).
“Looking ahead to 2025, FDA together with the other Orbis countries plan to continue and expand collaborative efforts between regulatory authorities to support global oncology drug development and regulatory review,” the authors of the annual report stated.
OCE also provided a progress assessment for their Real-Time Oncology Review (RTOR) project, established in 2018, which is piloting a new review process that would enable FDA to use “topline results and datasets, after datasets are locked, to support an earlier start to the application review.” They noted that in 2020, there were three NME or original Biologics License Applications (BLA) applications and 13 supplemental applications under RTOR.
In an update of Project Facilitate, an initiative to assist with expanded access request submissions, OCE said processing times have decreased and there was been an increase in requests within the first year of operation, but expanded access requests overall began to decline in April of 2020, “likely due to the pandemic.” Another OCE initiative, Project Renewal, designed to “update the labeling information for older oncology products,” is underway, they said.
Project Equity, an initiative that aims to increase clinical trial enrollment for minorities, and Project Silver, a similar initiative for geriatric clinical trial enrollment, also kicked off in 2020. OCE said these projects among OCE’s inclusion and diversity initiatives; other efforts in this sphere include Project Community and the OCE Summer Scholars Program. OCE also highlighted the start of Project Patient Voice, a patient-focused initiative of the side effects of cancer therapies.
“This is our attempt to communicate patient-reported outcome data from clinical trials to the medical community in a way that can assist healthcare providers in discussing the side effect profile of anti-cancer treatments with their patients,” the OCE report stated.
OCE Annual Report


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.