FDA Approves Telix’s Pixclara for Glioma Brain Cancer Imaging
Key Points
- The FDA approved Telix Pharmaceuticals’ Pixclara® for PET imaging in patients with glioma, a form of brain cancer.
- Pixclara is the first FDA-approved FET-PET imaging drug for glioma in the United States.
- The imaging drug helps physicians distinguish recurring or progressing glioma from changes caused by prior treatment.
- Pixclara is approved for adults and pediatric patients one month of age and older.
- The approval expands Telix’s precision-medicine and radiopharmaceutical diagnostics business.
Telix Pharmaceuticals (NASDAQ: TLX) said the U.S. Food and Drug Administration has approved Pixclara® (floretyrosine F 18), a radioactive diagnostic drug used with PET imaging to evaluate gliomas.
Pixclara is designed to help physicians determine whether changes seen after treatment are caused by recurrent or progressing brain cancer or by treatment-related effects.
Pixclara Helps Clarify Brain Scan Results After Glioma Treatment
Patients with glioma can show changes on brain imaging after treatment that may be difficult to interpret. Those changes can indicate that a tumor has returned or worsened, but they may also result from previous treatment.
Pixclara is used with PET imaging and other diagnostic evaluations to help doctors tell the difference between recurrent or progressive glioma and treatment-related change. The product is a diagnostic imaging agent, not a treatment for brain cancer.
First FDA-Approved FET-PET Imaging Drug for Glioma
Telix said Pixclara is the first FDA-approved FET-PET imaging drug for glioma in the United States.
FET-PET imaging is recommended in international clinical practice guidelines for glioma imaging, including NCCN Guidelines®. However, Telix said no FDA-approved FET-PET imaging product had previously been available to physicians in the United States.
Approval Covers Adults and Pediatric Glioma Patients
The FDA approval allows Pixclara to be used in adults and pediatric patients one month of age and older.
Gliomas are the most common form of central nervous system cancer. Telix said gliomas account for about 30% of all brain and central nervous system tumors and roughly 80% of all malignant brain tumors.
The company estimates that approximately 24,000 new glioma cases are diagnosed each year in the United States.
Pixclara Expands Telix’s Precision Medicine Business
Telix said the approval broadens its precision-medicine business and reinforces its position in radiopharmaceutical diagnostics and targeted radiopharmaceutical therapies.
The company said Pixclara could give physicians greater confidence when assessing glioma patients and planning treatment. By providing a new FDA-approved FET-PET imaging option, Pixclara may help address an unmet need in brain cancer diagnostics.
