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. 2021 Feb;62(2):149-155.
doi: 10.2967/jnumed.120.260455. Epub 2020 Dec 18.

68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership

Giuseppe Carlucci  1 , Robin Ippisch  2 , Roger Slavik  1 , Ashley Mishoe  2 , Joseph Blecha  2 , Shaojun Zhu  3
Affiliations

68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership

Giuseppe Carlucci et al. J Nucl Med. 2021 Feb.

Abstract

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.

Keywords: 68Ga-PSMA-11; FDA; PET/CT; approval; new drug application; oncology: GU; radiochemistry; radiopharmaceuticals.

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Figures

FIGURE 1.
FIGURE 1.
Structural formula of 68Ga-PSMA-11.
FIGURE 2.
FIGURE 2.
68Ga-PSMA-11 production method from UCLA NDA 212642.
FIGURE 3.
FIGURE 3.
68Ga-PSMA-11 production method (cyclotron-based) from UCSF NDA 212643.
FIGURE 4.
FIGURE 4.
68Ga-PSMA-11 production method (generator-based) from UCSF NDA 212643.
See this image and copyright information in PMC

References

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