Radiopharm Theranostics to Meet With US FDA on Phase 3 Brain Metastases Diagnosis Trial
MT Newswires Live
Aug 17
Radiopharm Theranostics (ASX:RAD) will meet with the US Food and Drug Administration (FDA) on Oct. 1 to seek alignment on the design of a phase 3 trial to evaluate its RAD101 imaging agent in patients with suspected recurrence of brain metastases following radiotherapy, according to a Monday filing with the Australian bourse.
The meeting will focus on the trial's design criteria, including the number of patients to be enrolled and the primary and secondary endpoints, per the filing.
The FDA will also review data from a phase 2b trial of RAD 101, which showed 93% concordance between MRI and PET imaging of brain metastases in the targeted patient population, the company said.
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