<sup>68</sup>Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership.
Where this comes from
- Record sourced from PubMed, PMID 33443068.
- Also identified by DOI 10.2967/jnumed.120.260455 and PMC identifier 8679592.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
The University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) codeveloped <sup>68</sup>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.
Medical subject headings
- Drug Approval
- Edetic Acid
- Oligopeptides
- United States Food and Drug Administration