'Promising' new PET agent for brain metastases put on FDA's Fast Track

A new imaging agent targeted at brain metastases has been granted the U.S. Food and Drug Administration’s Fast Track designation. 

RAD101, or ¹⁸F-RAD101, is a PET imaging agent used to differentiate recurrent brain metastases from treatment-related effects in patients with cerebral metastases that are the result of a solid tumor. Radiopharm Theranostics—the radiotherapeutics firm responsible for developing the agent—signaled that clinical trial results thus far have been promising, representing a significant step forward for the hundreds of thousands of patients affected by brain metastases. 

“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,” Riccardo Canevari, the CEO and managing director of Radiopharm Theranostics, said in an announcement. “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 reserved for drugs capable of treating serious conditions, especially those which lack effective therapeutics, which are expected to progress if left untreated. It expedites the review process and streamlines communication between the FDA, developers and researchers.  

Learn more about the imaging agent here.