Telix Announces New Drug Application for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent
Thursday, October 24, 2024
Telix has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®), an imaging agent for glioma.
Gliomas are the most common primary brain tumours in the central nervous system, particularly challenging to manage after treatment.
Traditional MRI techniques face limitations, such as reduced biological specificity, reliance on blood-brain barrier disruption, and difficulty in differentiating between tumour progression and treatment effects.
These issues often lead to inconclusive results and delays in crucial treatment decisions.
The FDA has granted the application priority review, with a PDUFA goal date of 26 April 2025, indicating a potential U.S. commercial launch next year.
Pixclara (18F-floretyrosine or 18F-FET) is a PET imaging agent designed to characterise progressive or recurrent glioma, distinguishing it from treatment-related changes in both adult and paediatric patients.
While FET PET is already used in international clinical guidelines for glioma imaging, the U.S. currently lacks an FDA-approved targeted amino acid PET agent for brain cancer imaging. Due to its potential to fulfil a significant unmet need, Pixclara has received orphan drug status and fast track designation from the FDA.
Precision imaging is vital in this field, where rapid decision-making is crucial due to low survival rates. Subject to regulatory approval, Pixclara aims to meet this need, offering patients clearer diagnostic insights and aiding treatment planning.
Telix is also exploring the possibility of using Pixclara as a companion diagnostic for TLX101-Tx, a neuro-oncology drug in development that targets the same amino acid transporter with therapeutic radiation.
If approved, Pixclara could significantly improve brain cancer imaging in the U.S., aligning it with international standards and enhancing patient care and outcomes.
Source: telixpharma.com
