On December 1, 2020, FDA approved a new drug application (NDA) for 68Ga-PSMA-HBED-11 (68Ga-PSMA-11) that was jointly submitted by the University of California, San Francisco (UCSF), and University of California, Los Angeles (UCLA). We applaud the work of the teams at both institutions and the FDA for bringing this important imaging agent for men with prostate cancer to market. This is the first PSMA PET agent approved in the U.S. Read the FDA press release for more details.
The FDA approval covers only drug product manufactured at UCSF and UCLA. Even if you have an IND for 68Ga-PSMA-11, your drug product is NOT FDA-approved. FDA will be in communication with you if there are changes to the status of your IND. You can proceed with research studies using your 68Ga-PSMA-11 IND until you receive notification from the FDA. UCSF and UCLA waived their right to exclusivity for the drug, which means that others can file an Abbreviated NDA (ANDA) for 68Ga-PSMA-11 with the same formulation and end-product specifications. Currently, the average time for approval of an ANDA from the FDA is about two years.
UCSF and UCLA have NOT registered to distribute 68Ga-PSMA-11; therefore, the only centers that administer an FDA-approved dose are UCSF and UCLA. However, centers around the country are doing research studies with 68Ga-PSMA-11 and other PSMA PET agents. You can find them here. Note that there may be a charge for the scan that is not covered by insurance or Medicare/Medicaid.
FDA has approved other PET prostate imaging agents over the past eight years. Fluciclovine F-18 (Axumin®) is widely available throughout the U.S. You can locate centers here. Choline C-11 is also approved by FDA and available at centers in the U.S.
Imaging and management of prostate cancer is a rapidly evolving field that is harnessing the potential of molecular imaging to help improve the lives of men with prostate cancer.