Telix has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®), an imaging agent for glioma.Gliomas are the most common primary brain tumours in the central nervous system, particularly challenging to manage after treatment. Traditional MRI techniques face limitations, such as reduced biological specificity, reliance on blood-brain barrier disruption, and difficulty in differentiating between tumour progression and treatment effects. These issues often lead to inconclusive results and delays in crucial treatment decisions.The FDA has granted the application priority review, with a PDUFA goal date of 26 April 2025, indicating a potential U.S.

Telix宣布，美国食品和药物管理局（FDA）已接受TLX101 CDx（Pixclara®）的新药申请（NDA），TLX101 CDx是一种神经胶质瘤成像剂。神经胶质瘤是中枢神经系统中最常见的原发性脑肿瘤，治疗后尤其难以控制。传统的MRI技术面临着局限性，例如生物学特异性降低，依赖血脑屏障破坏以及难以区分肿瘤进展和治疗效果。这些问题往往导致不确定的结果和关键治疗决策的延误。FDA已批准申请优先审查，PDUFA的目标日期为2025年4月26日，表明美国有可能。

commercial launch next year.Pixclara (18F-floretyrosine or 18F-FET) is a PET imaging agent designed to characterise progressive or recurrent glioma, distinguishing it from treatment-related changes in both adult and paediatric patients. While FET PET is already used in international clinical guidelines for glioma imaging, the U.S.

明年进行商业发布。Pixclara（18F-氟乙烯基松香或18F-FET）是一种PET显像剂，旨在表征进行性或复发性神经胶质瘤，将其与成人和儿科患者的治疗相关变化区分开来。虽然FET PET已经用于神经胶质瘤成像的国际临床指南，但美国。

currently lacks an FDA-approved targeted amino acid PET agent for brain cancer imaging. Due to its potential to fulfil a significant unmet need, Pixclara has received orphan drug status and fast track designation from the FDA.Precision imaging is vital in this field, where rapid decision-making is crucial due to low survival rates.

目前缺乏FDA批准的用于脑癌成像的靶向氨基酸PET试剂。由于其有可能满足大量未满足的需求，Pixclara已获得FDA的孤儿药地位和快速通道指定。。

Subject to regulatory approval, Pixclara aims to meet this need, offering patients clearer diagnostic insights and aiding treatment planning. Telix is also exploring the possibility of using Pixclara as a companion diagnostic for TLX101-Tx, a neuro-oncology drug in development that targets the same amino acid transporter with therapeutic radiation.If approved, Pixclara could significantly improve brain .

Telix还在探索使用Pixclara作为TLX101-Tx的伴随诊断的可能性，TLX101-Tx是一种正在开发的神经肿瘤药物，其靶向具有治疗性辐射的相同氨基酸转运蛋白。如果获得批准，Pixclara可以显着改善大脑。