FDA issues response for TLX101
The FDA has issued a complete response letter (CRL) to the new drug application (NDA) seeking the approval of TLX101-CDx (18F-floretyrosine [18F-FET]; Pixclara) for use in the imaging of glioma.
The FDA has issued a complete response letter (CRL) to the new drug application (NDA) seeking the approval of TLX101-CDx (18F-floretyrosine [18F-FET]; Pixclara) for use in the imaging of glioma. After reviewing the NDA, the FDA informed Telix Pharmaceuticals—the developer of TLX101-CDx—that additional confirmatory clinical evidence will be required to support approval. No safety concerns were raised in the CRL. Telix Pharmaceuticals intends to request a meeting with the FDA to review the reasons for the CRL.
18F-FET is a PET agent intended to characterize progressive or recurrent glioma based on treatment-related changes in adult and pediatric patients. Some global guidelines currently include FET PET for the imaging of gliomas; however, no targeted amino acid PET agents are currently approved by the FDA for imaging in patients with glioma. TLX101-CDx is designed to target the LAT and LAT29 membrane transport proteins, which could also allow the agent to be utilized as a companion diagnostic agent for TLX101 (131I-iodofalan [131I-IPA]), a LAT1-directed agent under investigation in glioblastoma.
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