Radiopharm gets FDA nod on design of RAD101 phase III study

Sydney-based Radiopharm Theranostics said it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a phase III trial for RAD101, its PET imaging agent for patients whose brain metastases are indeterminate after radiotherapy. 

According to final minutes from the company’s end-of-phase II meeting with the agency, the multicenter trial is expected to enroll about 280 patients with brain metastases from a range of solid tumors. Its co-primary endpoints are the sensitivity and specificity of RAD101 PET against a defined reference standard, the company said. RAD101 (F-18 fluoropivalate) is a small molecule that targets fatty acid synthase, an enzyme overexpressed in brain metastases from solid tumors. It already holds FDA fast track designation. 

The FDA reviewed phase 2b data showing 93% concordance between MRI and RAD101 PET in patients with suspected recurrence, including tracer uptake in lesions that were equivocal on MRI, Radiopharm said. 

Siemens Healthineers will manufacture and distribute F-18 RAD101 doses for the U.S. trial. Radiopharm expects to select a contract research organization (CRO) in the fourth quarter of 2026 and begin dosing patients in the first half of 2027.