|
|
|
Posted 18 April 2024 PM
Melbourne radiopharmaceutical company Telix has landed a Fast Track designation from the FDA, as it progresses what is likely to be its third commercial product.
The designation was awarded to LX101-CDx, branded Pixclara, for the characterisation of progressive or recurrent glioma using positron emission tomography (PET). There is no FDA-approved targeted PET agent for brain cancer imaging in the US, although it's currently included in both the US and European guidelines for the imaging of gliomas.
The company is in the final stages of preparing its New Drug Application for Pixclara for both adult and paediatric patients. Telix aims to make the product commercially available in the US where around 22,000 new cases of glioblastoma are diagnosed each year.
It will be assisted in this by an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF), which will support joint development and commercialisation.
 |
| Richard Valeix |
"There is critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting, and we are excited to leverage the clinical experience at UCSF to help make this investigational agent more widely available," UCSF Professor of Radiology, Thomas Hope, said.
"Pixclara has the potential to help determine if a glioma is truly progressing or undergoing a treatment-induced change, known as pseudo-progression, where MRI, the standard of care, can often be inconclusive."
For manufacturing and pharmacy distribution, Telix has a commercial agreement with PharmaLogic Holdings to supply finished unit doses to the US market.
"These milestones represent significant progress as we bring this investigational product closer to market in the US and commercial launch," Telix CCO, Richard Valeix, said. "PharmaLogic has rapidly developed an excellent reputation for manufacturing radiopharmaceuticals to rigorous quality standards and will deliver a key component of Telix's supply chain strategy for TLX101-CDx in the US, subject to regulatory approval."
Telix currently has two commercialised products, Illucix for prostate cancer in the US, Australia, and Canada, and Scintimun for osteomyelitis in approximately 30 countries. Those are both imaging products, but the company is looking to ride the wave of radiopharmaceuticals as the technology is increasingly used for treatment.
James Quintana Pearce
If you were passed this article by a colleague, chances are you've missed other important Pharma in Focus articles and features.
To find out more, go to www.pharmainfocus.com.au and sign up for a FREE Full Text trial
Pharma in Focus
Australia's most trusted source of pharma news
© Copyright Lush Media. End of News - printed 03 January 2026