The FDA has issued a complete response letter (CRL) to the new drug application (NDA) seeking the approval of TLX101-CDx (

FDA已向寻求批准TLX101-CDx的新药申请（NDA）发出了一封完整回应信（CRL）。

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F-floretyrosine [

F-氟酪氨酸 [

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F-FET]; Pixclara) for use in the imaging of glioma.

F-FET]; Pixclara）用于胶质瘤成像。

The FDA has issued a complete response letter (CRL) to the new drug application (NDA) seeking the approval of TLX101-CDx (

美国食品药品监督管理局（FDA）已向寻求批准TLX101-CDx的新药申请（NDA）发出了一封完整回应信（CRL）。

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F-floretyrosine [

F-氟酪氨酸 [

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F-FET]; Pixclara) for use in the imaging of glioma.

F-FET]; Pixclara）用于胶质瘤成像。

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..

在审核了新药申请（NDA）后，FDA告知TLX101-CDx的开发者Telix Pharmaceuticals，需要额外的确证性临床证据来支持批准。完整回应函（CRL）中并未提及任何安全性问题。Telix Pharmaceuticals计划请求与FDA召开会议，以审查CRL的原因。

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F-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.

F-FET是一种PET显像剂，旨在根据成人和儿童患者治疗相关的变化来表征进展性或复发性胶质瘤。一些全球指南目前包括FET PET用于胶质瘤成像；然而，目前尚无靶向氨基酸PET显像剂被FDA批准用于胶质瘤患者的成像。

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 (.

TLX101-CDx 旨在靶向 LAT 和 LAT29 膜转运蛋白，这也可能使其作为 TLX101 的伴随诊断剂使用。

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I-iodofalan [

I-碘法兰 [

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I-IPA]), a LAT1-directed agent under investigation in glioblastoma.

I-IPA]），一种在胶质母细胞瘤中研究的LAT1导向药物。

Condition:

条件：

Glioblastoma

胶质母细胞瘤

Type:

类型：

drug

药物