镓-PSMA-11 NDA 获批：新颖且成功的学术合作。
Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership.
机构信息
Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; and.
Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, California.
出版信息
J Nucl Med. 2021 Feb;62(2):149-155. doi: 10.2967/jnumed.120.260455. Epub 2020 Dec 18.
The University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) codeveloped Ga-PSMA-11 by conducting a bicentric pivotal phase 3 clinical trial for PET imaging for prostate cancer. On December 1, 2020, 2 separate new drug applications (NDAs) submitted by each institution (NDA 212642 for UCLA and NDA 212643 for UCSF) were approved by the Food and Drug Administration as the first drug for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. This article briefly describes the background, clinical development, regulatory approach, and regulatory process for NDA filing and approval. In the second part of this article, key chemistry, manufacturing, and controls (CMC) information is provided to facilitate abbreviated new drug application (ANDA) submission.
加利福尼亚大学洛杉矶分校（UCLA）和加利福尼亚大学旧金山分校（UCSF）合作开展了一项针对前列腺癌的 Ga-PSMA-11 的双中心关键阶段 3 临床试验，以开发该药物。2020 年 12 月 1 日，这两所机构分别提交了两项新药申请（NDA）（UCLA 的 NDA 212642 和 UCSF 的 NDA 212643），均获得了美国食品和药物管理局（FDA）的批准，成为首个用于 PSMA 阳性前列腺癌男性前列腺特异性膜抗原（PSMA）阳性病变的正电子发射断层扫描（PET）成像药物。本文简要介绍了新药申请（NDA）备案和审批的背景、临床开发、监管方法和监管流程。本文的第二部分提供了关键的化学、制造和控制（CMC）信息，以促进简略新药申请（ANDA）的提交。
Zotero 插件