FDA Grants Fast Track Designation to Radiopharm Theranostics’ RAD101 for Brain Metastases Imaging

A new imaging agent designed to detect brain metastases has received Fast Track designation from the U.S. Food and Drug Administration. Known as RAD101 (18F-RAD101), this PET imaging agent helps distinguish between recurrent brain metastases and treatment-related effects in patients whose cerebral metastases stem from solid tumors. Radiopharm Theranostics, the company developing RAD101, reports that early clinical trial results have been encouraging, marking a meaningful advancement for the hundreds of thousands of patients living with brain metastases.

Riccardo Canevari, CEO and managing director of Radiopharm Theranostics, 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 pseudo progression. RAD101 represents a promising advancement in improving diagnostic precision for brain metastases, offering hope for more effective clinical decision-making in the over 300,000 patients diagnosed annually in the U.S.” 

The agent targets the multi-enzyme protein fatty acid synthase, which is known to be overexpressed in many solid tumors. It is currently being tested alongside the use of contrast-enhanced MRI brain scans to determine concordance between lesions identified on both modalities. The ability to differentiate between metastases and the residual effects of stereotactic radiosurgery is critical for managing treatment. 

The FDA’s Fast Track designation is granted to drugs that address serious conditions with limited or no existing treatments, particularly those likely to worsen without intervention. The program accelerates the review process and enhances communication among the FDA, drug developers, and researchers.