OHSU Research Drives FDA Approval For Novel Use of Anemia Drug In Brain Cancer Imaging
The Food and Drug Administration has approved ferumoxytol, known clinically as FERABRIGHT™, as a contrast agent physicians can use to detect and monitor tumor progression in patients with brain cancer.
Ferumoxytol is an iron-based substance that has been primarily used to treat anemia. Research into a novel use of the substance — to improve imaging of tumors — began in an Oregon Health & Science University laboratory nearly 30 years ago, with efforts led by Edward Neuwelt, M.D., a professor and lead researcher in OHSU’s Department of Neurology and founder of OHSU’s Neuro-Oncology Blood-Brain Barrier Program.
Now, the successful completion of the decades-long project means a new tool to battle brain cancer. Physicians can use this new imaging option to see an additional, multidimensional view of the cancerous area in the brain.
Approval through the FDA required a New Drug Application, known as an NDA, an intensive process that Neuwelt started in 2011. Over the last five years, a core team of researchers in Neuwelt’s group — including Muir, Amy Huddleston, M.P.A: HA, Leslie Muldoon, Ph.D., Rochelle Fu, Ph.D., and Laszlo Szidonya, M.D., Ph.D. — worked to help bring the project across the finish line, including designing three new studies based on data from existing OHSU clinical trials; collecting and analyzing data in response to FDA requirements; and providing documentation throughout the FDA inspection and review process.