FDA Agrees to Single Pivotal Phase 3 Trial Design for Brain Metastases Imaging Agent RAD101

Radiopharm Theranostics has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a single pivotal Phase 3 trial for RAD101, its imaging agent for brain metastases. The trial will involve approximately 280 patients with indeterminate brain metastases from various solid tumor types after radiotherapy, with co-primary endpoints focusing on sensitivity and specificity. RAD101, which selectively binds to fatty acid synthase, aims to provide more accurate detection of cancer cells in the central nervous system.