Telix Pharmaceuticals announced Monday that it is eyeing a 2024 rollout of what it says is the first targeted PET imaging agent for kidney cancer.
The Melbourne, Australia-based company recently submitted its license application to the U.S. Food and Drug Administration for the investigational positron emission tomography agent TLX250-CDx (Zircaix). It has already been granted a rolling review process, with Telix pushing for priority consideration.
“This is a major milestone and achievement for Telix, which paves the way for a commercial availability for patients in the U.S. in 2024, subject to regulatory review and approval,” Christian Behrenbruch, PhD, MBA, managing director and Telix Group CEO, said in a Dec. 18 announcement.
The company said the submission follows Phase 3 of its ZIRCON study (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: NCT03849118), which reported meeting key endpoints in November 2022.
“The ZIRCON study demonstrated the superior sensitivity and specificity of this advanced diagnostic imaging agent, which, if approved, will be the first and only agent available to target carbonic anhydrase IX, a highly relevant target in kidney cancer,” Brian Shuch, MD, director of the kidney cancer program at the UCLA Institute of Urologic Oncology, said in the same announcement. “This delivers on a major unmet need to provide confidence in the diagnosis of [clear cell renal cell carcinoma], the most aggressive and common form of kidney cancer.”
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.