On December 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), a radioactive diagnostic agent administered via intravenous injection, for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
This marks the first approval for a drug of its kind and is indicated for patients with suspected prostate cancer metastasis that may be curable by surgery or radiation therapy. It is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen levels.
The safety and efficacy of Ga 68 PSMA-11 were evaluating in 2 trials enrolling 960 men with prostate cancer.
In the first trial, 325 patients underwent PET/CT or PET/MRI scans with Ga 68 PSMA-11. These patients were eligible for surgical removal of the prostate gland and pelvic lymph nodes. Of those who proceeded to surgery, those with positive readings in the pelvic lymph nodes on Ga 68 PSMA-11 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology.
“The availability of this information prior to treatment is expected to have important implications for patient care. For example, it may spare certain patients from undergoing unnecessary surgery,” they wrote in the press release.
In the second trial, 635 patients received a single Ga 68 PSMA-11 PET/CT scan or PET/MRI scan. These patients had rising serum PSA levels after initial prostate surgery or radiotherapy. The scans showed 74% of patients had ≥1 positive lesion detected by Ga 68 PSMA-11 PET. Of these patients, an estimate 91% had confirmed local recurrence or metastasis of prostate cancer.
No serious adverse events (AEs) were associated with Ga 68 PSMA-11. The most common AEs with Ga 68 PSMA-11 were nausea, diarrhea and dizziness.—Janelle Bradley
Source: US Food and Drug Administration. FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer. December 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targeted-pet-imaging-drug-men-prostate-cancer. Accessed December 1, 2020
