FDA to Review NDA for TLX101-CDx: A Promising Glioma Imaging Agent
A new drug application for TLX101-CDx, an investigational PET imaging agent designed to differentiate progressive or recurrent glioma from treatment-related changes, has been submitted to the FDA.
- A new drug application (NDA) was submitted to the FDA for TLX101-CDx (Pixclara; 18F-floretyrosine).
- This investigational PET agent helps characterize progressive or recurrent glioma from treatment-related changes.
- TLX101-CDx previously was granted FDA orphan drug and fast track designations.
The FDA has received an NDA for TLX101-CDx, an investigational PET imaging agent for the characterization of glioma.1
Currently, there are no FDA-approved, commercially available, targeted amino acid PET agents to help image brain cancer in adult and pediatric patients. TLX101 shows potential to address this unmet need as the agent can help patients receive greater clarity in their diagnosis and treatment decision making.
TLX101-CDx is being developed as the companion theranostic imaging agent for TLX101, an investigational neuro-oncology drug candidate being developed by Telix Pharmaceuticals Limited. This agent attacks the same amino acid transporter mechanism with therapeutic targeted radiation.
"Gliomas are the most common primary brain tumors of the central nervous system. Conventional imaging with MRI often yields inconclusive results in characterizing recurrent disease and therefore delays time-sensitive decision making. Limitations of conventional imaging techniques include the lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes,” said Kevin Richardson, chief executive officer, Telix Precision Medicine, in a press release.
Tumor in brain: © peterschreiber.media - stock.adobe.com
“Telix's filing of this NDA for [TLX101-CDx] is an important milestone, reflecting our commitment to improved and accessible neuro-oncology imaging in the US, and taking us one step closer to commercial availability in 2025, subject to FDA approval," continued Richardson.
The investigational therapy TLX101 uses a small molecule as it needs to cross the blood-brain barrier. This is the protective barrier that blocks many potential drug candidates from entering the brain.2
TLX101 is being evaluated in frontline and recurrent glioblastoma in the IPAX series of studies which include IPAX-1 (NCT03849105) and IPAX-2 (NCT05450744).
Both TLX101 and TLX101-CDx have already been granted orphan drug and fast track designations from the FDA .
