Radiopharm Theranostics (ASX:RAD), a clinical-stage biopharmaceutical company developing innovative radiopharmaceuticals for oncology, announced that the US Food and Drug Administration has granted fast track designation to its novel imaging agent RAD101.
The designation supports the development of RAD101 for distinguishing between recurrent brain metastases and treatment-related effects, including radiation necrosis and pseudoprogression, in patients with metastases originating from various solid tumours.
RAD101 is a small molecule imaging agent targeting fatty acid synthase, a protein overexpressed in numerous solid tumours, including those that metastasize to the brain.
This fast track status underscores the significant unmet need in diagnosing and managing recurrent brain metastases, which affect over 300,000 patients annually in the US.
Radiopharm CEO Riccardo Canevari emphasised the importance of the FDA's decision, noting that RAD101 may enhance diagnostic accuracy and guide more effective treatment strategies.
The company is currently conducting a US-based Phase 2b clinical trial involving 30 patients.
The study aims to evaluate the diagnostic performance of 18F-RAD101, focusing on concordance with standard MRI imaging, as well as sensitivity, specificity, and accuracy in differentiating tumour recurrence from post-treatment effects.
Fast track designation allows for accelerated FDA review processes, including more frequent communication, rolling submissions, and potential eligibility for priority review.