Comment from Reboot Rx

RE: Docket No. FDA-2026-N-4492; Drug Repurposing for Unmet Medical Needs; Request for Information. Submitted by Reboot Rx. Reboot Rx is a nonprofit focused on advancing affordable cancer treatments by repurposing generic drugs. Our attached response to the RFI addresses the four topics: 1. Priority areas We recommend including oncology as a priority disease area given the increasing burden of cancer, management of some cancers as chronic diseases, and the large number of generic drugs with published clinical evidence supporting new uses. 2. Candidates for drug repurposing We highlight three generic drugs that are supported by evidence from randomized controlled trials and warrant FDA evaluation under Scenario 1: (1) 5-alpha reductase inhibitors (5-ARIs; finasteride and dutasteride) for prostate cancer during active surveillance, (2) transdermal estradiol patches for locally advanced prostate cancer, and (3) aspirin for stage II-III PI3K-altered colorectal cancer. 3. Approaches to identifying candidates for drug repurposing We describe Reboot Rx’s approach, which combines AI-enabled literature surveillance, structured evidence extraction, clinical trial and treatment guideline analysis, and expert review into a continuously updated drug repurposing intelligence platform. 4. Barriers and opportunities We propose solutions to repurposing barriers including: (1) federal funding for definitive randomized controlled trials and (2) pathways for nonprofits to independently seek FDA approval of new uses when manufacturers are not interested in submitting a supplement to a new drug application. We present a “labeling-only” 505(b)(2) pathway concept and other approaches. Please see our full response in the attached document. Reboot Rx would welcome the opportunity to serve as a resource to the FDA and other federal partners as this effort develops. You can reach us at info@rebootrx.org.