Telix重新向林业发展局申请Pixclara,这是用于区分脑肿瘤复发和治疗效果的PET成像剂,但美国尚未批准类似的申请。 Telix resubmits FDA application for Pixclara, a PET imaging agent to distinguish brain tumor recurrence from treatment effects, with no similar U.S. approval yet.

Telix药品公司已重新向FDA提交TLX101-Px (Pixclara) 的新药申请,该药是一种PET成像剂,旨在区分脑癌患者的复发性质瘤与与治疗相关的变化. Telix Pharmaceuticals has resubmitted a New Drug Application to the FDA for TLX101-Px (Pixclara), a PET imaging agent aimed at distinguishing recurrent glioma from treatment-related changes in brain cancer patients. 重新提交的材料包括补充数据和分析,以解决林业发展局在前一份全面回应函中的关切。 The resubmission includes additional data and analyses addressing FDA concerns from a prior Complete Response Letter. 这些药剂针对的是LAT1和LAT2蛋白质,并具有快车道和孤儿药品名称。 The agent targets LAT1 and LAT2 proteins and has Fast Track and Orphan Drug designations. 美国目前没有经林业发展局批准的针对脑癌的氨基酸PET成像剂,从而产生了大量未得到满足的需求。 No FDA-approved targeted amino acid PET imaging agent is currently available in the U.S. for brain cancer, creating a significant unmet need. 患者倡导团体对FDA对扩大获取计划的持续参与和支持表示欢迎. The FDA’s ongoing engagement and support for an Expanded Access Program have been welcomed by patient advocacy groups. Telix的PSMA瞄准剂Gozellix在美国得到批准,TLX101-Px及其配方疗法TLX101-Tx仍在调查之中,尚未获得任何地方的销售批准。 While Telix’s PSMA-targeting agent Gozellix is approved in the U.S., TLX101-Px and its companion therapy TLX101-Tx remain under investigation and have not yet received marketing approval anywhere.