Project facilitate: Innovation and advancement in FDA’s oncology expanded access program.

Abstract

e18556 Background: FDA Oncology Center of Excellence’s (OCE) Project Facilitate (PF) was launched in June 2019 in response to perceived barriers providers face when accessing Expanded Access (EA). Since launch, PF continues to evolve and innovate to provide a comprehensive service to assist oncology healthcare providers requesting EA. An analysis of single-patient investigational new drugs (IND) was performed over 1 year to assess the growth and impact of the program. Methods: Data was extracted from Project Facilitate’s central database that yielded 640 single-patient INDs between June 1, 2020 and June 1, 2021. Data collected included IND receipt date, granting date, status, application type, indication, drug name, address of requestor, and patient demographics. Results: Of the 640 single-patient INDs extracted, there were 183 emergency INDs (eIND) and 457 non-emergency INDs (SPI). EA requests originated primarily from academic centers (81%) and community hospitals (18%) whereas Veterans Affairs and Military Treatment Facilities (0.5%) and Other (0.5%) were the least common. The 5 most common states requests originated from include New York (14%), California (13%), Texas (11%), Pennsylvania (7%), and North Carolina (4%). Although the current FDA Form 3926 does not request race and ethnicity information, this data was reported in 17 requests: White (8), Asian (3), Black/African American (3), American Indian or Alaskan Native (0), Native Hawaiian or Other Pacific Islander (0), Hispanic or Latino (3) and non-Hispanic or Latino (0). Age distribution was analyzed for pediatric (24%) and adult (76%) patients. Age distribution was further analyzed in geriatrics >75 (10%), in pediatrics < 2 (7%) and patients 2-17 years old (17%). The processing and review times for 630 applications were <1 day (96%) and > 1 day (4%). PF granted 100% of EA requests received in this time period. PF’s call center received 525 phone calls of which 499 (95%) were answered on the first call. PF also received 7843 emails during this period. Conclusions: Since 6/1/2020, PF started performing the reviews, processing and granting of CDER oncology EA requests that generally were performed by the FDA Review Divisions. By consolidating this process to PF, review times have drastically reduced to <1 day. PF has evolved since launch to promote effective and equal access to oncology expanded access.[Table: see text]

Taking AIM at serious illness: implementing an access to investigational medicines expanded access program

“…In 2019, FDA announced the launch of the Oncology Center for Excellence (OCE) Project Facilitate, a pilot program to assist oncology providers in requesting access to investigational therapies for patients with cancer through EA pathway and to streamline the regulatory authorization process. In the year following its launch, Project Facilitate supported 640 single patient IND requests ( 5 ) and continues to serve an important role in streamlining EA support. The Center for Disease Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have also streamlined the submission/review process for non-emergency EA applications through creation of the CDER NextGen portal.…”