FDA approved generic gallium Ga 68 gozetotide injection for PET imaging of PSMA-positive lesions in prostate cancer.
The FDA has approved an abbreviated new drug application (ANDA) for the generic version of the radioactive diagnostic agent Gallium Ga 68 Gozetotide Injection (Ga-68 PSMA-11) for PET imaging of prostate-specific membrane antigen (PSMA)–positive lesions in patients with prostate cancer.1
RadioMedix, the developer of Ga-68 PSMA-11, completed an FDA inspection of its manufacturing site in connection with the approval. No Form 483 observations were reported during the inspection.
“FDA approval of our Ga68 PSMA-11 ANDA represents an important milestone for RadioMedix and reinforces our commitment to expanding availability of cost-effective and high-quality radiopharmaceuticals for patients,” Ebrahim S. Delpassand, MD, founder and chief executive officer of RadioMedix, stated in a news release. “We are also proud to have completed the FDA inspection with no Form 483 observations, which reflects the rigor of our quality systems, manufacturing capabilities, and teamwide commitment to regulatory excellence. As the radiopharmaceutical field continues to grow, quality, consistency, and regulatory readiness will be essential to ensuring these technologies can reliably reach patients.”
In December 2020,
PSMA-PreRP enrolled patients with biopsy-proven prostate cancer who were considered candidates for prostatectomy and pelvic lymph node dissection (n = 325). Each patient received a single gallium Ga-68 PSMA-11PET/CT or PET/MR from mid-thigh to skull base.
Findings from the study revealed that Ga-68 PSMA-11 produced a positive predictive value of 61% (95% CI, 41%-81%) and a negative predictive value of 84% (95% CI, 79%-91%). In terms of diagnostic performance, the sensitivity and specificity values were 47% (95% CI, 29%-65%) and 90% (95% CI, 84%-96%), respectively.
PSMA-BCR was a 2-center study that enrolled patients with biochemical evidence of recurrent prostate cancer after definitive therapy (n = 635), defined by a serum PSA level above 0.2 ng/mL more than 6 weeks after prostatectomy or by an increase in serum PSA of at least 2 ng/mL above nadir after definitive radiotherapy. All patients received a single Ga-68 PSMA-11 PET/CT or PET/MR from mid-thigh to skull base.
Among patients with a PSA level less than 0.5 ng/mL (n = 48), the PET positivity rate with Ga-68 PSMA-11 was 36% (95% CI, 27%-44%). Among patients with a PSA level of at least 0.5 ng/mL and less than 1 ng/mL (n = 44), the PET positivity rate was 56% (95% CI, 45%-67%). Those with PSA levels of at least 1 ng/mL and less than 2 ng/mL (n = 71) and those with levels of at least 2 ng/mL (n = 299) experienced PET positivity rates of 83% (95% CI, 75%-91%) and 91% (95% CI, 88%-94%), respectively.
In terms of safety, no serious adverse reactions were attributed to Ga-68 PSMA-11 in either study.2 The most common adverse reactions to Ga-68 PSMA-11 included nausea, diarrhea, and dizziness. In a news release, the FDA noted that Ga-68 PSMA-11 carries a risk for misdiagnosis as well as a risk of long-term cumulative radiation exposure, which is associated with an increased risk for cancer.
