Setback for Telix Pharmaceuticals (ASX:TLX) as FDA Requests Additional Data for Brain Cancer Imaging Agent

April 28, 2025 12:48 PM AEST | By Team Kalkine Media

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Setback for Telix Pharmaceuticals (ASX:TLX) as FDA Requests Additional Data for Brain Cancer Imaging Agent — Image source: shutterstock

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Highlights

FDA issues complete response letter for TLX101-CDx application

No safety concerns raised for investigational brain cancer imaging agent

Telix Pharmaceuticals to pursue additional clinical strategies for resubmission

Telix Pharmaceuticals (ASX:TLX) has captured attention after receiving a disappointing update from the US Food and Drug Administration (FDA) regarding its glioma imaging agent, TLX101-CDx. The biopharmaceutical company, headquartered in Melbourne, focuses on developing and commercializing therapeutic and diagnostic radiopharmaceuticals targeting unmet needs in oncology and rare diseases, with operations spread across the US, Brazil, Canada, Belgium, Switzerland, and Japan.

The recent development involves the FDA issuing a complete response letter (CRL) for the company's new drug application (NDA) for TLX101-CDx, an agent designed for imaging glioma, a rare and life-threatening form of brain cancer. The FDA concluded that the application could not be approved in its current form, requesting additional confirmatory clinical evidence to support the drug's efficacy. Importantly, the FDA did not cite any concerns regarding the product’s safety profile.

Despite engaging in a detailed consultation process during the submission and review stages, Telix Pharmaceuticals faces this unexpected hurdle. In response, the company is seeking a hearing with the FDA to better understand the decision and is exploring pathways to strengthen its submission through additional clinical data from active and ongoing studies.

Telix Pharmaceuticals emphasized that this development is particularly disheartening for American glioma patients, especially considering that FET-PET imaging, which TLX101-CDx is based on, is regarded as best practice internationally. The agent has already received orphan drug and fast track designations from the FDA, reflecting its potential to address significant unmet medical needs and its promise over existing imaging methods.

Dr. Christian Behrenbruch, Managing Director and CEO of Telix Pharmaceuticals, reiterated the company's commitment to advancing TLX101-CDx, aiming to improve clinical management decisions for glioma patients through enhanced imaging. The company is focused on rapidly addressing the FDA’s feedback and enhancing its application with robust clinical evidence.

While the regulatory delay introduces some uncertainty, particularly amid broader changes in US healthcare policy under the new administration, it does not impact Telix Pharmaceuticals' FY25 financial guidance, which already excludes projections from unapproved products. This situation presents a temporary obstacle, and the company's proactive approach suggests efforts are well underway to overcome it and continue progressing its innovative healthcare solutions.

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