The Food and Drug Administration (FDA) has accepted a new drug application for Plxclara (TLX101-CDx), a glioma-imaging agent, Pixclara manufacturer Telix Pharmaceuticals has announced.
The application, Telix announced in a news release, has been granted priority review and a designated Prescription Drug User Fee Act goal date of April 26, 2025, meaning that the FDA has until that date to decide whether to approve the agent.
Glossary
New Drug Application: When a drug sponsor proposes that the FDA approves a new drug for sale and marketing in the United States.
Priority Review: When the FDA intends to take action on an application within six months, as opposed to the 10 months of a standard review.
Orphan Drug Designation: A designation granted by the FDA to a drug or biological product to prevent, diagnose or treat a rare disease or condition.
Fast Track Designation: A process intended to facilitate the development of and expedite the review of drugs by the FDA to treat serious conditions and fill an unmet medical need.
A positron emission tomography (PET) agent for the characterization of progressive or recurrent glioma from treatment-related changes in adult and pediatric patients, Pixclara has already received orphan drug designation and fast track designation from the FDA.
“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,” stated Kevin Richardson, chief executive officer of Telix Precision Medicine, in the news release. “There is currently a critical need for better imaging in brain cancer.”
Glioma is a type of tumor that starts in the glial cells, defined by the National Cancer Institute as cells that hold nerve cells in place and help them work the way they should. Gliomas, according to the American Cancer Society, include tumor types such as astrocytomas (which include glioblastomas), oligodendrogliomas and ependymomas, and approximately 30% of all brain tumors are gliomas. Additionally, the American Cancer Society states that most fast-growing brain tumors are gliomas.
In total, the American Cancer Society estimated that there would be approximately 25,400 malignant tumors of the brain and spinal cord diagnosed in adults and children in 2023, and that approximately 18,760 people would die from brain and spinal cord tumors that year.
Pixclara, according to the news release, is designed to target the membrane transport proteins LAT and LAT2. LAT and LAT2 are targets that are highly expressed in solid tumors including central nervous system malignancies, according to Telix. The agent may also be used as a companion diagnostic agent to Telix’s LAT1-targeting investigational glioblastoma therapy, TLX101 (131I-iodofalan, or 131I-IPA). TLX101 is currently being investigated in the IPAX-201 and IPAX-Linz11 clinical trials.
Telix stated in an April news release that it had an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF), which is conducting clinical research into the use of Pixclara in a number of neurological malignancies.
Dr. Thomas A. Hope, professor of radiology at the university, said at the time, “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. [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.”
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