Telix has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TLX101-Px (Pixclara, F-18 floretyrosine), its investigational PET imaging agent for characterizing recurrent or progressive glioma in adult and pediatric patients.
The resubmission includes additional data and statistical analysis requested by the FDA in a Complete Response Letter, according to the company. Pixclara has received both orphan drug and fast track designations from the FDA, given its potential to address unmet medical needs, Telix said.
PET imaging with F-18 floretyrosine is already included in international clinical practice guidelines for glioma imaging, but no FDA-approved targeted amino acid PET agent for brain cancer imaging is currently commercially available in the U.S., Telix noted.
