Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the opening of an expanded access program (EAP) in the United States (U.S.) for TLX101-CDx (Pixclara™1, 18F-floretyrosine or 18F-FET) an investigational positron emission tomography (PET) agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration (FDA) agreement to proceed.
Amino acid PET is included in U.S. and European clinical practice guidelines for the imaging of gliomas2, however there is no FDA-approved targeted amino acid PET agent for brain cancer imaging currently available in the U.S. Telix’s goal is to make this product commercially available in the U.S., significantly increasing patient access to this important imaging agent for both adult and paediatric patients. The Company expects to file its New Drug Application (NDA) for TLX101-CDx with the FDA during Q3 2024.
Patrick Wen, MD, Professor, Neurology, Harvard Medical School and Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, said, “Amino acid PET imaging of the brain is increasingly used to supplement conventional imaging by MRI3, which for many years has been the primary clinical imaging modality in patients with glioma at all stages of disease. After treatment, MRI has several limitations, including the lack of biological specificity, dependency on blood-brain barrier disruption, and an inability to differentiate between tumour progression or recurrence from treatment-related changes. TLX101-CDx (FET-PET) shows potential to provide a more rapid and conclusive diagnosis, inform treatment decisions and deliver a new standard for the management of gliomas in the U.S.”
David N. Cade, MD, Telix Chief Medical Officer, added, “As we finalise the submission of our NDA for TLX101-CDx, the opening of this expanded access program will enable us to provide continued access to this investigational agent, where there is significant unmet medical need in the U.S. Glioma is the most common and aggressive form of primary brain cancer and we believe TLX101-CDx has the potential to make an important difference for U.S. glioma patients who deserve greater reliability in their diagnosis and treatment decision making.”
Under its EAPs – sometimes also called ‘compassionate use’ – the FDA works with companies to allow access to investigational products, outside of a clinical trial, to patients with serious or life-threatening illnesses, for whom there are no comparable or satisfactory alternate options.
U.S. patients, or physicians who may have eligible patients in the U.S. can e-mail eap-americas@telixpharma.com or complete the form here for further information about the TLX101-CDx EAP.
Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.
About TLX101-CDx
TLX101-CDx (Pixclara™1) is a PET imaging agent, which has been granted fast track4 and orphan drug5 designations by the FDA as an imaging agent for the characterisation of glioma. TLX101-CDx targets membrane transport proteins known as LAT1 and LAT26. This enables TLX101-CDx to be potentially utilised as a companion diagnostic agent to TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA), Telix’s LAT1-targeting investigational glioblastoma (GBM) therapy, currently under investigation in the IPAX-27 and IPAX-Linz8 studies.
About gliomas in the U.S.
Gliomas are very diffusely infiltrative tumours that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumours and 80% of all malignant brain tumours9. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.10. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients11, with an expected survival duration of 12-15 months from diagnosis12.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the FDA8, by the Australian Therapeutic Goods Administration (TGA) 9, and by Health Canada10. No other Telix product has received a marketing authorisation in any jurisdiction.
