Shots:
- The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients
- The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing tumor progression from treatment-related changes
- TLX101-Px is designed to improve neuroimaging of recurrent or progressive glioma, with 18F-FET PET already recommended in international clinical guidelines, including NCCN
Ref: Telix | Image: Telix | Press Release
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