FDA accepts previously rejected application for new PET imaging agent
The U.S. Food and Drug Administration has accepted Telix Pharmaceuticals’ application seeking approval for a new PET imaging agent after rejecting the previous attempt.
Headquartered in Melbourne, Australia, the radiopharma firm hopes to eventually begin selling Pixclara (Floretyrosine F 18), an investigational product for glioma, a type of brain cancer. Telix previously reported a year ago that its last application had been rejected by the FDA, with regulators contending it lacked key clinical evidence.
Authorities are targeting a Prescription Drug User Fee Act goal date of Sept. 11, according to Telix. Experts believe, once approved, that Pixclara stands to address a significant unmet medical need in the U.S.
“Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care,” Patrick Wen, MD, chair of neuro-oncology at the Mass General Brigham Cancer Institute, Boston, said in a statement April 10. “PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA’s acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States.”
Experts note that such PET imaging already is broadly recommended in clinical guidelines across the globe. Given this key unmet need, Pixclara already has earned Fast Track and Orphan Drug designations from the U.S. FDA for the characterization of recurrent or progressive glioma. In the U.S., there are about 24,000 new glioma cases diagnosed annually, with it representing the most common form of central nervous cancer.
Telix previously announced the submission of its application to the FDA in March and noted Friday that it does not expect to collect revenue from the drug in 2026.
“The FDA’s acceptance of our [New Drug Application] resubmission is an important milestone for Telix,” added Kevin Richardson, CEO precision medicine for the company, which also has offices in Indianapolis. “We appreciate the FDA’s constructive engagement and look forward to working closely with the agency to urgently obtain approval and then bring this product to market for the benefit of patients.”
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.