FDA grants priority review for new brain cancer imaging agent
The U.S. Food and Drug Administration has granted priority review for an application from drugmaker Telix Pharmaceuticals, which is seeking to roll out a new imaging agent for brain cancer.
Pixclara (18F-FET) is a positron emission tomography product for the characterization of progressive or recurrent gliomas—a group of tumors that form in the brain and spinal cord. International clinical practice guidelines include such FET-PET for the imaging of gliomas, but there currently is no FDA-approved, targeted amino acid PET agent available for commercial purchase in the U.S.
Melbourne, Australia-based Telix hopes it can fill this need, noting that the priority review could result in its imaging agent becoming available sometime in 2025.
“Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the U.S. and bring it into line with a more advanced standard of care currently used in other markets,” Kevin Richardson, CEO of precision medicine, said in an Oct. 23 announcement. “There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes.”
Conventional MRI techniques for gliomas have limitations, Telix noted, including a lack of specificity, dependency on blood-brain barrier disruption, and an inability to differentiate between tumor progression and treatment-related causes. This can lead to inconclusive results and delays in treatment.
The U.S. FDA has designated Pixclara as an orphan drug, meaning it would not be profitable to produce without government assistance, due to the small population impacted. Telix said it also is reviewing the potential use of Pixclara as a companion diagnostic agent for TLX101-Tx. The investigational, neuro-oncology drug is currently in development and would target the same amino acid transporter mechanism with therapeutic targeted radiation.
Gliomas are the most common form of central nervous system neoplasm that originate from glial cells. They account for about 30% of all brain and CNS tumors and 80% of all malignant brain tumors, Telix noted. In the U.S., there are about 6 cases of gliomas diagnosed per 100,000 individuals each year.
The announcement is one of several in the past week from the pharmaceutical firm. Telix also:
- On Oct. 22 announced the spin-off of a new company, Rhine Pharma, with the mission of expanding access to radiopharmaceuticals for cancer imaging and treatment.
- On Oct. 17 said that it has filed a Form 20-F registration statement with the U.S. Securities and Exchange Commission as it seeks to begin trading company shares on the Nasdaq.
- And on Oct. 17 announced that it had collected quarterly revenue of $135 million, primarily generated from sales of its prostate cancer imaging product Illuccix. This represented an increase of 55% from Q3 2023 revenues and 9% over the previous quarter in 2024.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.