1st patients dosed with newly approved brain cancer imaging agent
Imaging leaders are celebrating the first patients being dosed with a newly approved brain cancer imaging agent.
Indianapolis-based Indiana University Health says it is the first hospital system in the U.S. to administer Pixclara, a pharmaceutical used to help radiologists evaluate suspected recurrent disease. IU believes this marks an “important step forward in precision oncology,” reinforcing its commitment to advancing theranostics.
Green lit by the Food and Drug Administration in September and manufactured by Telix, Pixclara is a radioactive diagnostic drug paired with positron emission tomography imaging. Already part of the standard of care overseas, this marks the first U.S. FDA-approved FET-PET—short for PET imaging with floretyrosine F 18—drug for glioma.
“Our physicians, researchers, technologists and clinical teams have spent years advancing this work. Today, patients are benefiting from that expertise,” Dennis Murphy, president and CEO of IU Health, said in a statement Oct. 6. “As Indiana’s largest health system and an academic health center, IU Health has a unique opportunity to move promising discoveries from research into real-world patient care.”
Since 2020, IU clinical teams have performed over 700 advanced brain tumor imaging scans through clinical research. This has helped contribute to the evidence base and expertise that paved the way for this approval, Murphy and colleagues note.
In its own announcement, Telix said that University Hospitals’ Cleveland Medical Center also was among the first to administer the drug in the U.S. This marks the start of commercial availability for Pixclara, it said, with distribution partner PharmaLogic Holdings Corp. supplying finished doses to the U.S. market.
Gliomas are the most common form of central nervous system cancer, accounting or about 30% of CNS tumors and 80% of all malignant brain tumors, Telix estimated. This translates to about 24,000 new cases diagnosed each year, “representing a significant unmet addressable need.”
“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,” Kevin Richardson, CEO of Telix Precision Medicine, said in a statement. “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.”
You can read more about the drug and its uses in our coverage from last month.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.