18F-FET

TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation

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Lundi, avril 15, 2024
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MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).

Key Points: 
  • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).
  • The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET).
  • Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.
  • This designation enables expedited review and closer consultation with the FDA during the review process.

Telix Collaborates with Olivia Newton-John Cancer Research Institute on Brain Cancer Imaging Study

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Mercredi, décembre 22, 2021
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Glioblastoma (GBM) is the most common primary brain cancer in adults representing approximately 50% of brain tumours.

Key Points: 
  • Glioblastoma (GBM) is the most common primary brain cancer in adults representing approximately 50% of brain tumours.
  • ONJCRI is leading the FIG Study with an Australian consortium1 and has secured over $3 million in research grant funding from the Medical Research Future Fund (MRFF), Cure Brain Cancer Foundation and MRFF-Australian Brain Cancer Mission.
  • Telix funding will specifically support an observational study (registry) which will collect data demonstrating the value of FET-PET imaging in brain cancer patients.
  • This is a more functional imaging technique compared to magnetic resonance imaging (MRI), the current standard imaging tool, and could potentially provide a powerful imaging biomarker for the management of brain cancer and improve survival rates.