The FDA has signed off on the first-ever imaging drug for glioma more than a year after it initially rejected the diagnostic.
Telix’s Pixclara (floretyrosine F-18 or 18F-FET) works as an amino acid positron emission tomography (PET) drug for imaging gliomas. Around 80% of all malignant brain tumors are gliomas, with around 24,000 cases in the U.S. every year.
Pixclara is used with PET to distinguish recurrent or progressive glioma from treatment-related change, in line with other diagnostics, in adults and children one month of age and older.
This FET-PET combo is recommended in international clinical practice guidelines for the imaging of gliomas, but there has not been a drug approved in the U.S. to meet these criteria.
Pixclara changes that, giving doctors in the U.S. “more certainty in their diagnoses and greater confidence in their treatment planning for patients,” Telix Precision Medicine CEO Kevin Richardson said in a statement.
The approval of Pixclara has not been easy. Last April, the FDA rejected the drug’s application, explaining in a letter that Telix needed “additional confirmatory clinical evidence” before it could assess and approve Pixclara.