(68)Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership.
(68)Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership.
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（68）Ga-PSMA-11 NDA批准：一种新颖而成功的学术合作伙伴关系。
DOI：
10.2967/jnumed.120.260455
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Zhu S
中科院分区：
文献类型：
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作者：
Carlucci G;Ippisch R;Slavik R;Mishoe A;Blecha J;Zhu S
加州大学洛杉矶分校（UCLA）和加州大学旧金山分校（UCSF）共同开发了68Ga-PSMA-11，开展了一项用于前列腺癌PET成像的双中心关键3期临床试验。2020年12月1日，各机构提交的两份独立新药申请（NDA） （UCLA的NDA 212642和UCSF的NDA 212643）获得了美国食品和药物管理局（fda）的批准，成为首个用于前列腺癌男性前列腺特异性膜抗原（PSMA）阳性病变PET成像的药物。本文简要介绍了NDA申报和批准的背景、临床发展、监管方法和监管过程。在本文的第二部分，提供了关键的化学，制造和控制（CMC）信息，以方便简略的新药申请（ANDA）提交。
The University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) codeveloped 68Ga-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.