FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara
The FDA has approved Telix Pharmaceuticals' New Drug Application for Pixclara (floretyrosine F 18), making it the first FDA-approved FET-PET imaging drug for glioma, the most common form of brain and central nervous system cancer. The PET imaging agent is indicated to differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients one month of age and older. Approximately 24,000 new U.S. glioma cases are diagnosed each year, and FET-PET imaging is already recommended in international guidelines including NCCN, but no FDA-approved product was available in the U.S.
Key figures
- Drug Name
- Pixclara (floretyrosine F 18, (18)F-FET)
- Phase Of Trial
- Phase 3 (registrational study for potential brain metastases indication expansion)
- Us annual glioma cases
- 24000
- Safety population patients
- 382
- Glioma pct of brain cns tumors
- 30%
- Glioma pct of malignant brain tumors
- 80%
AI analysis
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