Telix Submits Revised New Drug Application for Brain Cancer Imaging Agent TLX101-Px to FDA

Telix Pharmaceuticals has announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its PET imaging agent, TLX101-Px (Pixclara®), designed for differentiating recurrent or progressive glioma from treatment-related changes. This resubmission includes additional data requested by the FDA and aims to address the Complete Response Letter previously issued.

TLX101-Px has received both Orphan Drug and Fast Track designations from the FDA due to its potential to address significant unmet needs in brain cancer imaging. Currently, there is no FDA-approved targeted amino acid PET agent available in the U.S. specifically for the imaging of adult and pediatric brain cancer.

Dr. David N. Cade, Chief Medical Officer at Telix, emphasized the importance of improving glioma diagnosis and management in the post-treatment setting. "Our resubmission is supported by an extensive and compelling data set—particularly so for an orphan indication," stated Dr. Cade.

The Head for the Cure Foundation's Executive Director, Maggie Haynes, also highlighted the community's optimism regarding the FDA’s ongoing support for the drug. She expressed hope for an expedited review process to make this imaging option available to patients in need.

TLX101-Px functions by targeting L-type amino acid transporters 1 and 2 (LAT1 and LAT2), and holds potential as a companion diagnostic agent for Telix’s LAT1-targeting glioblastoma therapy candidate, TLX101-Tx (iodofalan 131I), currently under study in the IPAX-BrIGHT trials.

Gliomas are highly infiltrative tumors originating from glial cells, accounting for 30% of brain and CNS tumors in the U.S. Annually, about 22,000 new cases of glioblastoma multiforme (GBM), a high-grade form of glioma, are diagnosed in the country. Standard treatment often includes surgery, followed by radiotherapy and chemotherapy, yet recurrence is common, with a median survival time of 12-15 months post-diagnosis.

Telix has noted that neither TLX101-Px nor TLX101-Tx has received marketing authorization in any jurisdiction to date.