Radiopharm Theranostics (ASX:RAD) Receives FDA Fast Track for RAD101
FDA Fast Track Designation
Radiopharm Theranostics has been granted Fast Track Designation by the U.S. Food and Drug Administration for its RAD101 imaging agent, aimed at distinguishing between recurrent disease and treatment effects in brain metastases from various solid tumors, including leptomeningeal disease. The designation is intended to expedite the development and review of drugs addressing serious conditions with unmet medical needs.
Clinical Trial Progress
RAD101, Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN), is currently in a Phase 2b clinical trial in the U.S., evaluating its diagnostic performance in 30 individuals with confirmed recurrent brain metastases. Positive data from a Phase 2a trial at Imperial College London indicated significant tumor uptake and potential for non-invasive overall survival prediction, supporting the ongoing studies.
Executive Comments
CEO Riccardo Canevari stated, “The FDA’s Fast Track Designation for RAD101 highlights the seriousness of recurrent brain metastases as a condition and the unmet medical need for innovative products that can differentiate between tumor recurrence and radiation necrosis or pseudoprogression.”
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