FDA rejects application for new brain cancer imaging agent
The U.S. Food and Drug Administration has denied an application for a new investigational imaging agent used to diagnose glioma, a rare form of brain cancer.
Australian radiopharmaceutical firm Telix announced the setback for its product Pixclara on Monday. In its response letter, the FDA said it cannot approve the New Drug Application for the PET agent in its current form, contending additional clinical evidence is required.
Telix said this decision comes despite a “robust consultation process” with the FDA prior to submission. Authorities have not raised concerns about the product’s safety, and Telix plans to request a hearing to review the basis for the decision.
“This is a disappointing outcome for American glioma patients,” the company said in an April 28 announcement. “FET-PET is recommended medical best practice in relevant international oncology practice guidelines and is used extensively in other parts of the world. The FDA has granted TLX101-CDx Orphan Drug and Fast Track designation, a tacit acknowledgement of the drug candidate's importance in addressing a significant unmet medical need and clinically demonstrating benefit over existing medical solutions.”
Telix remains committed to commercializing Pixclara and improving care for glioma patients, with leaders assessing strategies to address the agency’s concerns. The FDA rejection does not impact the company’s financial forecasts for 2025, which excludes revenue predictions for unapproved products.
“We have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including company-led studies,” Christian Behrenbruch, PhD, MBA, Telix’s managing director and group CEO, said in the announcement. “Our immediate focus is understanding the FDA’s feedback and augmenting our submission with additional data to satisfy the agency as soon as possible.”
Telix also recently reported quarterly earnings results, which included $151 million in sales from flagship imaging agent Illuccix, used for prostate 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.