‘Game changer’: FDA approves first PSMA-targeted PET imaging tracer for men with prostate cancer
The U.S. Food and Drug Administration on Tuesday approved the first radiopharmaceutical for PET imaging of prostate-specific membrane antigen lesions in men with prostate cancer.
Two top University of California medical centers—UC San Francisco and UCLA—received approval for Gallium-68 PSMA-11, the organizations announced Dec. 1. Each remarked in a statement that it is “rare” for academic institutions to obtain federal drug approval.
Ga-68 PSMA-11 is for use in patients whose cancer is believed to have spread but is potentially curable via surgery or radiation therapy.
“Ga-68 PSMA-11 is an important tool that can aid healthcare providers in assessing prostate cancer,” Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research, said in a statement. “With this first approval ... providers now have a new imaging approach to detect whether or not cancer has spread to other parts of the body.”
Two prospective clinical trials helped push this imaging agent over the regulatory finish line. In one, 960 men with prostate cancer received a Ga-68 PSMA-11 injection with PET/CT or PET/MR imaging. Results showed the agent helped identify patients who were good candidates for surgery.
The second trial enrolled 635 men with elevated serum PSA levels after they had previously undergone prostate surgery or radiotherapy. The now-approved agent detected at least one lesion in 74% of these patients.
“I believe PSMA-PET imaging in men with prostate cancer is a game-changer because its use will lead to better, more efficient and precise care,” Peter Carroll, MD, MPH, a professor at the UCSF Helen Diller Family Comprehensive Cancer Center, said in a university news item about the approval.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.