Telix Pharmaceuticals has secured an agreement with the US Food and Drug Administration (FDA) on how to resubmit its application for TLX101-CDx, an experimental imaging agent for glioma.
The company said the new filing is expected in the fourth quarter (Q4) of 2025. The FDA agreement follows a Type A meeting between the regulator and Telix. According to the company, the revised application will include a fresh confirmatory analysis of existing clinical data, aimed at addressing issues raised in earlier reviews.
“We’ve worked with relative speed to reach a mutually agreed path forward,” said David Cade, Telix’s chief medical officer. “Our focus remains on making this imaging agent available to patients in the US.”
Glioma is a rare and aggressive brain cancer where accurate imaging is critical for diagnosis and treatment planning. TLX101-CDx, branded Pixclara, uses fluorine-18 to highlight tumors in scans, potentially offering doctors a sharper tool to detect the disease.
Setbacks and Data Requests
The road to this point has been uneven. In 2024, the FDA rejected Telix’s first attempt to win approval, issuing a Complete Response Letter (CRL) that flagged gaps in the evidence. Regulators called for additional data, particularly to back up the drug’s efficacy claims.
Telix faced a choice: run a new trial or make a deeper analysis of existing studies. It has opted for the latter, betting that re-examined data can satisfy the FDA’s demands while avoiding years of delay. The company believes its updated package will directly address the shortcomings cited in the CRL.
Once resubmitted, the FDA will set a new review deadline under the Prescription Drug User Fee Act (PDUFA). The agency has signaled that an expedited review is possible, citing the lack of effective imaging options for glioma.
In the meantime, US patients can continue to access TLX101-CDx through an expanded access program. Telix has also made clear that no potential revenue from the drug is included in its 2025 forecasts, reflecting the uncertain timeline for approval.
