Radiopharm Theranostics is partnering with Siemens Healthineers on a clinical supply agreement under which Siemens will radiolabel and distribute RAD101, Radiopharm's F-18–labeled small molecule imaging agent targeting fatty acid synthase (FASN) for the diagnosis of suspected recurrent brain metastases from solid tumors.
Under the agreement, Siemens Healthineers will manufacture and distribute doses of F-18–labeled RAD101 to support Radiopharm's upcoming phase III registrational trial in the U.S.
Data from an interim analysis in the phase IIb trial of RAD101 showed 90% concordance between PET imaging and MRI, with significant and selective tumor uptake in brain metastases, Radiopharm said.
The U.S. Food and Drug Administration (FDA) has granted RAD101 Fast Track Designation for distinguishing between recurrent disease and treatment effect in brain metastases from solid tumors, including leptomeningeal disease.
