The U.S. Food and Drug Administration (FDA) has ruled that Telix Pharmaceuticals' New Drug Application(NDA) for TLX101-CDx (Pixclara) cannot be approved in its current form.
In a statement, Melbourne, Australia-based Telix said that the FDA's Complete Response Letter (CRL) stated that the agency required additional confirmatory clinical evidence in order to advance the application for Pixclara, Telix’s investigational agent for glioma imaging.
The firm said that there had been “a robust consultation process prior to submission and during review of the NDA.”
Pixclara (Floretyrosine F-18 or F-18 FET) is a PET agent that helps characterize progressive or recurring glioma. FET-PET is recommended in international oncology practice guidelines for glioma imaging, Telix added.
The FDA had also granted Pixclara Orphan Drug and Fast Track designations, according to the firm.
Telix said that it was requesting a hearing with the FDA to review the basis for the decision and is assessing clinical strategies to supplement the application in the near term.
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