FDA to review glioma imaging agent, sets September decision date
Telix candidate TLX101-Px has US fast track, orphan drug designations
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The U.S. Food and Drug Administration (FDA) has agreed to review an application from Telix Pharmaceuticals seeking approval of TLX101-Px, the company’s experimental imaging agent for glioma, with a decision expected by Sept. 11.
“The FDA’s acceptance of our [application] is an important milestone for Telix,” Kevin Richardson, CEO of Telix Precision Medicine, said in a company press release. “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.”
Gliomas are cancers of the central nervous system (the brain and spinal cord) that arise from the uncontrolled growth of glia, a diverse group of cells that support and protect nerve cells. Because these cancers are deep within the body, clinicians rely on imaging technologies such as MRI and PET scans to detect gliomas and monitor tumor response to treatment.
Detecting tumor growth
In a PET scan, a radioactive tracer is injected into the body. The tracer sticks to certain types of cells or structures and is taken up by cells, acting like a dye, so those structures will light up on the scan. TLX101-Px, also known as floretyrosine F 18 or 18F-FET, aims to highlight two proteins, LAT1 and LAT2 (L-type amino acid transporter types 1 and 2).
The idea is to make it easier for clinicians to distinguish tumor growth from changes in tumor shape triggered by treatment — a distinction that can be difficult with available imaging tools. Telix is also seeking approval of the investigational imaging agent in Europe. If it’s approved in the U.S., Telix plans to market the agent under the name Pixclara.
“Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care,” said Patrick Wen, MD, endowed chair in neuro-oncology at Mass General Brigham Cancer Institute. “PET imaging with [TLX101-Px] 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.”
The FDA has granted TLX101-Px both fast-track status — which aims to speed the development of important new therapeutic tools — and orphan drug designation, which offers incentives for companies developing therapies designed to improve care for people with rare diseases.
“There remains a critical unmet need in improving our ability to image residual glioma after treatment,” said Thomas Hope, MD, vice chair of the radiology and biomedical imaging department at the University of California San Francisco. “We have worked with Telix for the last three years to help leverage our clinical data to help make [TLX101-Px] available to patients in the United States.”
Telix is developing the imaging agent in parallel with TLX101-Tx (iodofalan 131I), an experimental glioma treatment targeting the LAT1 protein. The ongoing Phase 3 IPAX BrIGHT trial (NCT07100730) is testing add-on TLX101-Tx against standard of care alone in people with an aggressive form of glioma called glioblastoma. That trial, which is open to adults whose cancer has recurred or progressed following available treatments, is recruiting participants at sites in Australia, Austria, and the Netherlands.
