Telix Pharmaceuticals Announces FDA Acceptance of New Drug Application for Pixclara® Brain Cancer Imaging Agent

Asian Aussie Business Times | Telix Pharmaceuticals Limited Announces FDA Acceptance of New Drug Application for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent

MELBOURNE, Australia | Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) has announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®), an imaging agent for glioma. The application has been granted priority review with a PDUFA goal date set for April 26, 2025, paving the way for a commercial launch in the U.S. in 2025.

Pixclara (18F-floretyrosine or 18F-FET) is a PET agent for characterizing progressive or recurrent glioma in both adult and pediatric patients. FET PET is already included in international clinical practice guidelines for glioma imaging. Pixclara has been designated as an orphan drug and granted fast track designation by the FDA due to its potential to address significant unmet medical needs.

There is a critical need to improve the diagnosis and management of gliomas, the most common primary brain tumors of the central nervous system. Conventional MRI imaging techniques have limitations in differentiating between tumor progression and treatment-related changes, leading to inconclusive results and delayed treatment decisions.

Pixclara has the potential to address this need for precision imaging, providing clarity in diagnosis and treatment decision-making for patients in the U.S. Telix is also exploring the use of Pixclara as a companion diagnostic agent for TLX101-Tx, an investigational neuro-oncology drug targeting the same amino acid transporter mechanism with therapeutic radiation.

Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, stated, “Telix believes that FDA approval of Pixclara will revolutionize brain cancer imaging in the U.S. and improve patient outcomes. There is a critical need for advanced imaging in brain cancer, and Telix is committed to delivering precision medicine solutions to address these needs.”

About TLX101-CDx

TLX101-CDx (Pixclara) is a PET imaging agent designated as an orphan drug by the FDA for characterizing glioma. It targets membrane transport proteins LAT and LAT2, potentially serving as a companion diagnostic agent for TLX101, Telix’s investigational therapy for glioblastoma.

About Gliomas in the U.S.

Gliomas are infiltrative tumors affecting the brain tissue, with glioblastoma being the most common and aggressive form of primary brain cancer. Despite current treatments, recurrence is common, with a short expected survival duration from diagnosis.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on developing diagnostic and therapeutic radiopharmaceuticals. Headquartered in Melbourne, Australia, Telix has operations internationally and aims to address unmet medical needs in oncology and rare diseases.

For more information about Telix, visit www.telixpharma.com or follow Telix on X and LinkedIn. Contact Telix Investor Relations for further inquiries.

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The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

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