Radiopharm granted U.S. FDA FTD for RAD101

Radiopharm (RADX) Theranostics announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation, FTD, for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. “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 pseudprogression,” said Riccardo Canevari, 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. We are excited to advance our Phase 2 clinical trial and anticipate sharing topline results in the second half of 2025.”