On August 27, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara[1], 18F-floretyrosine or 18F-FET), an investigational PET[2] agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients (Press release, Telix Pharmaceuticals, AUG 27, 2024, View Source [SID1234646129]).

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Given the potential to address significant unmet medical need, Pixclara1 has been granted Orphan Drug[3] and Fast Track[4] designation by the FDA, which facilitates expedited review and closer consultation with the agency during the review process. FET PET (Pixclara1) is already included in international clinical practice guidelines for the imaging of gliomas[5], however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

There is a critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. With low survival rates and the need to make rapid decisions, precision imaging is paramount. Subject to regulatory approval, Pixclara1 has the potential to address this need, enabling patients to receive greater clarity in their diagnosis and treatment decision making. Pixclara1 is also being developed as the "companion" theranostic imaging agent for TLX101, Telix’s investigational neuro-oncology drug candidate, which targets the same amino acid transporter mechanism with therapeutic targeted radiation.

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, stated, "Gliomas are the most common primary brain tumours of the central nervous system. Conventional imaging with MRI[6] often yields inconclusive results in characterising recurrent disease and therefore delays time-sensitive decision making4. Limitations of conventional imaging techniques include the lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumour progression or treatment-related causes[7]. Telix’s filing of this NDA for Pixclara1 is an important milestone, reflecting our commitment to improved and accessible neuro-oncology imaging in the U.S., and taking us one step closer to commercial availability in 2025, subject to FDA approval."

About TLX101-CDx

TLX101-CDx (Pixclara1) is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterisation of glioma. TLX101-CDx targets membrane transport proteins known as LAT1 and LAT2[8]. 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-2[9] and IPAX-Linz[10] 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 tumours[11]. 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.[12]. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients[13], with an expected survival duration of 12-15 months from diagnosis.