Telix To Resubmit NDA For Glioma Imaging Agent TLX101-CDx After FDA Guidance

Telix Pharmaceuticals announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the resubmission pathway for its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®), an investigational imaging agent for glioma, a rare and life-threatening brain cancer. The company confirmed it plans to resubmit the NDA in Q4 2025.

The decision follows a successful Type A meeting with the FDA, during which Telix received detailed guidance for its resubmission package. This will include an additional confirmatory efficacy study analysis of existing data, which Telix believes will satisfy the agency’s request for supplemental evidence and address matters raised in the prior Complete Response Letter (CRL).

Dr. David N. Cade, Telix Group Chief Medical Officer, said, “As previously advised, Telix had multiple options for delivering additional data requested by the FDA in the CRL response[3]. This flexibility has enabled us to work with relative speed to reach a mutually agreed path forward for resubmission of the NDA. We remain steadfastly focused on our goal of bringing this important imaging agent to patients in the U.S. to support improved diagnosis and management of glioma”.

Upon resubmission, the FDA will assign a new PDUFA goal date. The agency has recognized the significant unmet medical need in glioma imaging and indicated that the application will likely be considered for expedited review, subject to final acceptance. Meanwhile, Telix will continue to provide patient access to TLX101-CDx through its FDA-approved Expanded Access Program (EAP) until regulatory approval is achieved.