FDA Grants Fast Track Designation to Emerging Agent for Brain PET Imaging

The Food and Drug Administration (FDA) has issued a fast track designation for the ¹⁸F-RAD101 positron emission tomography (PET) imaging agent, which may help differentiate between treatment impacts on brain metastases and disease recurrence.

Radiopharm Theranostics, the developer of the PET agent, said 18F-RAD101 targets the multi-enzyme protein fatty acid synthase, which can be overexpressed in cerebral metastases and other solid tumors.

The ¹⁸F-RAD101 agent is currently being evaluated in a phase 2b multicenter clinical trial involving patients with recurrent brain metastases originating from solid tumors with different origins, according to Radiopharm Theranostics.

“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,” noted Riccardo Canevari, the CEO and managing director of Radiopharm Theranostics. “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.”