FDA denies pharma firm’s initial application for new kidney cancer imaging agent
The U.S. Food and Drug Administration has denied an Australia-based drugmaker’s initial application for a new PET imaging agent geared toward kidney cancer.
Telix Pharmaceuticals Ltd. announced the news on July 31, with the decision applying to its TLX250-CDx investigational agent for clear cell renal cell carcinoma (brand name Zircaix). The filing concern relates to demonstrating adequate sterility assurance during dispensing of the drug in the radiopharmacy production environment, Telix noted.
Despite these issues, all batches submitted as part of the application process passed the agency’s sterility requirements. Once eventually approved, Telix believes this will be the first targeted imaging agent for the noninvasive detection of renal cancer.
“We have been working closely with the FDA through the [Biologics License Application] rolling review due to the novel nature of this product candidate and value the FDA’s constructive feedback at this early stage in the process,” Christian Behrenbruch, PhD, MBA, managing director and group CEO at Telix, said in a statement. “We expect to be able to satisfy its requirements within a minimal time frame and continue to see a clear path to product commercialization in 2025.”
Telix emphasized that the FDA has not indicated any deficiencies in data relating to the clinical safety or efficacy of TLX250-CDx. The company expects to complete any remedial actions within 90 days and resubmit the application. Telix said it also plans to meet with the agency in the next month to reach an agreement on the “requisite submission amendments.”
The delay will have no impact on revenue forecasts nor research and development costs in 2024. Telix reaffirmed its previously issued revenue guidance of $490 million to $510 million (USD) this year.
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.