Ga-68-PSMA-11approvalFDAnew drug applicationThe University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) codeveloped Ga-68-PSMA-11 by conducting a bicentric pivotal phase 3 clinical trial for PET imaging for prostate cancer. On December 1, 2020, 2 separate...
TLX591-CDx是一种辅助制备镓-68gozetotide注射剂的试剂盒。 前列腺癌成像产品TLX591-CDx(Illuccix),旨在帮助制备镓-68(68Ga)gozetotide注射剂(PSMA-11)的试剂盒,已获得FDA批准,使基于68Ga的前列腺特异性膜抗原(PSMA)-PET的使用更容易 TLX591-CDx是FDA批准的首个商用产品,将扩大美国境内有资格接受68ga-PSMA-PE...
Ga 68 PSMA-11 is a radiopharmaceutical agent used in the diagnosis of prostate-specific membrane antigen (PSMA) positive lesions in male patients during positron emission tomography.
PSMA是对前列腺癌的影像监测、诊断与治疗过程中可利用的优质标志物和分子靶标。NY108对PSMA具有高亲和力,是诺宇医药针对前列腺癌领域的诊疗一体化产品管线,加载的诊断核素为68Ga,治疗核素为177Lu。诺宇医药的研发初衷是通过采用相同化合物结构来打破采用两种不同结构的诊疗药物配对的方法,实现真正意义上的诊疗一体化;...
Prostate-specific membrane antigen (PSMA) is expressed in the microvasculature of thyroid cancer. This suggests the potential use of PSMA as a diagnostic agent in patients with aggressive forms of thyroid cancer. The purpose of the current study was to d
The demand for 68Ga-labeled radiotracers has significantly increased in the past decade, driven by the development of diversified imaging tracers, such as FAPI derivatives, PSMA-11, DOTA-TOC, and DOTA-TATE. These tracers have exhibited promising results in theranostic applications, fueling interest ...
The FDA approval of the two tracers [68Ga]Ga-DOTA-TOC and [68Ga]Ga-PSMA-11 (Hennrich and Eder 2021; Carlucci et al. 2021; Hennrich and Benešová 2020) and the update of the Ph. Eur. for accelerator-produced 68Ga highlights the increasing demand and relevance of cyclotron-produced ...
There are at least three sites, University of Iowa, Vanderbilt University, and Excel Diagnostics & Nu- clear Oncology Center holding approval from FDA for the use of 68Ga-labelled somatostatin analogues in the management of patients with NETs. Peptide based precursors of GMP grade for l...