Mitchell Chan, PharmD, BCPS
Cameron Wilson, PharmD, BCPS, BCCCP
Tamy Kim, PharmD
OCE Insights is developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Lieutenant Commander Mitchell Chan, PharmD, BCPS, Team Lead and Clinical Analyst, Lieutenant Cameron Wilson, PharmD, BCPS, BCCCP, Health Scientist, and Tamy Kim, PharmD, Director of Regulatory Affairs and Policy, discuss the past 5 years of Project Facilitate, an OCE initiative to provide personalized support to oncologists and health-care teams seeking the expanded access pathway for investigational drugs for individual patients.
What is Project Facilitate, and how has it evolved since its launch in 2019?
Richard Pazdur, MD
Project Facilitate is a national comprehensive program focused on facilitating expanded access (also known as compassionate use) for oncology drugs for individual patients. Our aim is to make expanded access equitable whether a request is submitted by a large institution or a small community practice with little or no regulatory support. OCE Director Richard Pazdur, MD, conceived the idea of a call center to assist oncology health-care teams in the process of submitting oncology single-patient expanded access applications. Project Facilitate was launched at the 2019 ASCO Annual Meeting.1,2
Since 2019, Project Facilitate has evolved into an efficient program that has expanded to more than a call center. In June 2020, a year after launch, Project Facilitate officially took over the review of oncology single-patient applications instead of triaging them to the clinical divisions for review. This internal transition helped shift the single-patient expanded access applications to Project Facilitate, freeing up vital resources for the clinical divisions within the Office of Oncologic Diseases (OOD).
Since then, average processing and review times decreased by more than 90% compared with before Project Facilitate. This meant that, on average, physicians and their teams were receiving FDA decisions in a matter of a few hours compared with up to 5 days on average.
An exciting improvement since the Project Facilitate launch was the evolution of our individualized training on the oncology single-patient expanded access pathway to providers, their teams, and regulatory personnel. These trainings range from a quick 10 minutes to up to 45 minutes, walking professionals through the process of submitting a single-patient expanded-access application while explaining how the regulatory pathway works and what to expect from the FDA. This flexibility has made single-patient expanded access more accessible to busy providers and teams while ensuring high-quality information is disseminated.
We’ve also increased our research with abstracts submitted to ASCO and other organizations. Project Facilitate assisted some of our FDA pediatric oncologists in performing research into expanded-access requests for pediatric patients with central nervous system tumors. Lastly, we’re trying to reach more health-care and regulatory professionals through outreach to institutions such as Veterans Affairs (VA). To date, we have provided training to VA staff from Florida, Arizona, and around New England.
Can you share any Project Facilitate data for the past 5 years?
Project Facilitate has published 4-year data in an abstract at the 2024 ASCO Annual Meeting, detailing metrics from June 1, 2020, to December 31, 2023.3 Our abstract reported 2,791 applications received during this 4-year time frame. June 1, 2020, was chosen as the start date since it was the official start of Project Facilitate performing reviews of OOD oncology expanded-access applications compared with before, when applications where triaged to each respective clinical division. When applications received and triaged by Project Facilitate for the 5-year time frame between June 1, 2019, and June 1, 2024 were included, 3,858 single-patient expanded-access applications were received.
What are the future goals of Project Facilitate?
We are forecasting an exciting future for Project Facilitate. Going forward, we’re focusing on advancing our primary mission to more rural and small practices, to provide individualized and personalized training and education. Project Facilitate is creating digital resources to help health-care and regulatory teams navigate some of the most common questions in single-patient expanded access. This includes a “cheat sheet” to aid professionals in submitting their application to the FDA and includes useful information on follow-up submissions.
Project Facilitate championed changes to Form 3926 (a streamlined form used by physicians to request expanded access for individual patients) to include optional entry of the patient’s race and ethnicity. Project Facilitate intends to use this information to obtain insights into patients receiving investigational drugs through expanded access. Race and ethnicity information will help us guide initiatives in racial, ethnic, and cultural communities to ensure we’re providing efficient and culturally competent resources.
We plan on continuing our research through future publications and abstracts to highlight some of the work Project Facilitate is doing and research we’re involved in. With our improved data management within Project Facilitate, we hope to provide useful insights using the information our program collects.
How can health-care and regulatory professionals reach out to Project Facilitate?
Health-care and regulatory professionals can contact Project Facilitate at ONCProjectFacilitate@fda.hhs.gov or 240-402-0004 between 8:00 AM and 4:30 PM ET to submit an oncology single-patient expanded-access application or to get assistance with inquiries. For after hours, weekend, and holiday emergency requests, please contact the FDA’s Emergency Call Center at 866-300-4374.
DISCLOSURE: The authors reported no conflicts of interest.
REFERENCES
1. Helwick C: Project Facilitate: FDA’s plan to ease expanded access to novel therapies. The ASCO Post. July 10, 2019.
2. Chan M, Kim T, Boehmer J, et al: Update on Project Facilitate at the Oncology Center of Excellence. The ASCO Post. February 25, 2020.
3. Chan M, Wilson C, Boehmer J, et al: Project Facilitate: An analysis of the increased utilization in the oncology single patient expanded access pathway. J Clin Oncol 42(16 suppl):11029, 2024.
