FDA approves new brain cancer imaging agent from Telix
The U.S. Food and Drug Administration has approved a new brain cancer imaging agent from Telix, the Australia-based pharma firm announced Monday.
Pixclara is a radioactive diagnostic drug paired with positron emission tomography imaging. It’s used to help doctors distinguish between returning brain cancer or harmless changes caused by previous treatments.
The agency’s approval of Telix’s New Drug Application comes after the company previously received a rejection from the agency last year.
“As the first FDA-approved PET imaging drug for glioma [a type of brain cancer], Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients,” Kevin Richardson, CEO of Telix Precision Medicine, said in a statement Sept. 14.
Telix noted that this is the first U.S. FDA-approved FET-PET—short for PET imaging with floretyrosine F 18—imaging drug for glioma. The approval will enable broad access in the U.S. to FET-PET imaging, which is already recognized in international clinical practice guidelines, Richardson said. Pixclara is recommended for both adults and pediatric patients 1 month or older.
Gliomas are the most common form of central nervous system cancer, accounting for about 30% of all brain and CNS tumors, Telix noted. In the U.S., about 24,000 new glioma cases are diagnosed each year, with the approval expected to meet a “significant unmet addressable need.”
The drug’s safety was evaluated in nearly 400 patients with brain cancer. Among them, 371 adults received at least one IV dose of Pixclara, along with a dozen pediatric patients. Adverse reactions occurred in fewer than 0.5% of patients including headaches, nausea, injection site reaction, fatigue and malaise. The U.S. FDA previously rejected the application for Pixclara early last year, contending additional clinical evidence was needed at the time.
Regulators later accepted the application in April, with the imaging agent also earning Fast Track and Orphan Drug designations from the agency. Telix said at the time that it was targeting a Prescription Drug User Fee Act goal date of Sept. 11.
“Having an FDA-approved FET-PET product with high diagnostic accuracy will make a significant, positive difference to the management of patients with gliomas,” Patrick Wen, MD, chair of neuro-oncology at the Mass General Brigham Cancer Institute, Boston, said in the announcement. “This is a very positive step forward for brain cancer imaging and treatment planning.”
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.