Telix submits new brain imaging agent for FDA review following previous rejection
Radiopharmaceutical firm Telix has reignited its effort to gain U.S. Food and Drug Administration approval for a new brain cancer imaging agent.
The Australia-based company said Monday it has resubmitted its New Drug Application for Pixclara, an investigational PET product. It’s geared toward the characterization of recurrent or progressive glioma in both adult and pediatric patients.
Telix previously had announced in April 2025 that the FDA rejected its initial application, contending it required additional clinical evidence. Now, the company is returning armed with more info, hoping to satisfy regulators’ initial concerns.
“We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting,” David N. Cade, MBBS, MBA, Telix Group chief medical officer, said in a statement March 16. “Our resubmission is supported by an extensive and compelling data set—particularly so for an orphan indication,” he added, highlighting the special status granted to drugs that address rare diseases.
Based on recent consultation with the FDA, Telix believes the newly submitted data will address the agency’s previous red flags. Along with orphan drug status, Pixclara has earned Fast Track designation, which expedites the review of new drugs intended to treat serious conditions. International clinical practice guidelines endorse the use of PET imaging to address glioma. However, there currently is no FDA-approved, targeted amino acid imaging agent that’s commercially available in the U.S., Telix noted.
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, the company said. In the U.S., there are about 6 cases diagnosed per 100,000 people each year, with a critical need for new imaging agents.
“Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px,” Maggie Haynes, executive director, Head for the Cure Foundation, said in the announcement. “We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.”
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.