Telix Pharmaceuticals Limited (NASDAQ: TLX) announced that the first patients in the United States have received doses of Pixclara (floretyrosine F 18), its FDA-approved positron emission tomography (PET) imaging drug for glioma, a form of brain cancer.

According to a company statement, the initial doses were administered at Indiana University Health Neuroscience Center in Indianapolis and University Hospitals Cleveland Medical Center in Cleveland, Ohio. PharmaLogic Holdings Corp., Telix's U.S. manufacturing and pharmacy distribution partner, supplied the finished unit doses.

Pixclara is indicated to differentiate recurrent or progressive glioma from treatment-related change, used alongside other diagnostic evaluations, in adult and pediatric patients one month of age and older. The company describes it as the only FDA-approved radiopharmaceutical imaging drug for glioma.

Na Tosha N. Gatson, MD, PhD, director of the Center for Neuro-Oncology at IU Health, said, "Distinguishing recurrent or progressive gliomas from treatment-related change is one of the most difficult and consequential challenges in brain cancer. Having access to FDA-approved FET-PET imaging with Pixclara will help clinicians make more timely and accurate decisions."

Clement Pillainayagam, MD, a neuro-oncology specialist at University Hospitals Cleveland Medical Center, noted that FET-PET imaging is recommended in international clinical practice guidelines, including NCCN Guidelines, and that commercial availability could help translate that approach into broader patient access.

Gliomas account for approximately 30% of all brain and central nervous system tumors and about 80% of all malignant brain tumors. Roughly 24,000 new glioma cases are diagnosed annually in the U.S., according to data cited in the press release.

Pixclara is also the subject of a Phase 3 registrational study evaluating a potential expanded indication for the diagnosis of brain metastases. The most commonly reported adverse reaction in clinical trials involving 382 patients was headache, occurring in 0.5% of patients.