FDA approves first PSMA targeted PET imaging drug for prostate cancer patients

The FDA announced that it has approved the listing of the Ga 68 PSMA-11 (Ga 68 PSMA-11), jointly developed by UCLA and the University of San Francisco.
press release notes that this is the first drug approved for positive positive lesions of prostate-specific membrane antigens (PSMA) in male prostate cancer patients.
Ga 68 PSMA-11 is suitable for patients suspected of prostate cancer metastasis and may be cured by surgery or radiation therapy.
also suitable for patients who suspect a recurrence of prostate cancer based on elevated levels of serum prostate-specific antigens (PSA).
this is a radioactive diagnostic reagent, administered intravenously.
cancer is a common type of cancer in men.
the National Cancer Institute estimates that more than 190,000 new cases of prostate cancer will occur in the United States alone by 2020, with an estimated 33,000 deaths from the disease.
computerized fault scans (CT), magnetic resonance imaging (MRI) scans, and bone scans are common methods for imaging prostate cancer patients, but they have limitations in detecting prostate cancer lesions.
F 18 fluciclovine and C 11 choline are two other PET drugs approved for prostate cancer imaging, however, they are only approved for patients with suspected cancer recurrence.
the injection, Ga 68 PSMA-11 is able to bind to PSMA, an important pharmacological target for prostate cancer imaging, which is usually expressed at high levels in prostate cancer cells.
as a radiological drug that emits positive electrons, Ga 68 PSMA-11 can indicate the presence of PSMA-positive prostate cancer lesions in the body's tissues through PET imaging.
2 prospective clinical trials evaluated the safety and efficacy of Ga 68 PSMA-11.
in the first trial, 325 prostate cancer patients received PET/CT or PET/MRI scans using Ga 68 PSMA-11.
are candidates for surgical removal of the prostate and pelvic lymph nodes and are considered to have a higher risk of cancer metastasis.
in patients undergoing surgery, histological pathology studies showed that PET imaging showed a large proportion of patients who were positive for pelvic lymph nodes had cancer metastasis.
information before treatment is important for patient care.
, for example, may save some patients from unnecessary surgery.
second trial included 635 patients who showed signs of recurrence of prostate cancer by increasing serum PSA levels after initial prostate surgery or radiotherapy.
PET/CT scans or PET/MR scans based on Ga 68 PSMA-11 showed that 74% of patients tested positive for at least one PSMA-positive lesions in at least one body area (bone, prostate bed, pelvic lymph nodes, or extra-pelvic soft tissue).
91% of patients who tested positive for PET imaging subsequently confirmed a local recurrence or metastasis of prostate cancer using other tests.
, the second trial showed that PET imaging based on Ga 68 PSMA-11 could detect the site of the disease in patients with relapsed prostate cancer, providing important information that could affect treatment.
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