First Patients Dosed with Pixclara Following U.S. Commercial Launch for Glioma Imaging – Telix Pharmaceuticals
Telix Pharmaceuticals Limited announces that the first patients in the United States (U.S.) have been dosed with Pixclara (floretyrosine F 18 or 18F-FET), its FDA-approved, amino acid positron emission tomography (PET) drug for glioma (brain cancer) imaging.
The doses were administered at the Indiana University Health (IU Health) Neuroscience Center in Indianapolis and the University Hospitals, Cleveland Medical Center, Cleveland. The milestone marks the start of commercial availability for Pixclara, with Telix’s U.S. manufacturing and pharmacy distribution partner, PharmaLogic Holdings Corp. (PharmaLogic), supplying finished unit doses to the U.S. market.
Pixclara is a radioactive diagnostic drug indicated for use with PET to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients one month of age and older.
“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, minimizing uncertainty in their diagnoses and supporting more confident treatment planning for patients with gliomas.” – Na Tosha N. Gatson, MD, PhD, FAAN, director of the Center for Neuro-Oncology as part of the Neuroscience & Cancer Institutes with IU Health-Indiana University School of Medicine; tenured professor, Neurology, Neurosurgery, & Medicine, IUSM, and Founding President of the nonprofit, Living Oncology.
“The approval and commercial availability of Pixclara represents an advance for patients with glioma in the U.S. FET-PET imaging is recommended in international clinical practice guidelines, including NCCN Guidelines, and having an FDA-approved, commercially available option can help translate this established clinical approach into broader access for patients, adding another tool to help in their care.” – Clement Pillainayagam, MD, Specialist in Neurology and Neuro-oncology, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland.
“The first commercial dose of Pixclara is an important milestone for a patient community that has seen limited advances in diagnosis and treatment for many years. We are proud to support patients with glioma and their care teams by bringing this important new precision diagnostic to the U.S., and we thank the clinicians, patients, advocates and broader neuro-oncology community who helped make this possible.” – Kevin Richardson, Chief Executive Officer, Telix Precision Medicine.
