FDA approves first drug for PET imaging of suspected prostate cancer metastasis
The FDA approved Gallium 68 PSMA-11 (Ga 68PSMA-11), a drug for PET imaging of prostate-specific membrane antigen (PSMA) positive levels in men with suspected prostate cancer metastasis, who may be curable by surgery ir radiation therapy.
Ga 68 PSMA-11, which can also be used for patients with suspected prostate cancer recurrence, based onPSA levels, is a radioactive diagnostic agent given via intravenous injection. The drug can help determine treatment decisions, and spare individuals from unnecessary surgery.
“Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer”, said a researcher.
GA 68 PSMA-11 binds to PSMA- an antigen that usually occurs in elevated levels for men with prostate cancer. The radioactive drug emits positrons and can be seen on a PET scan, thus indicating prostate cancer within the body.
The drug was evaluated in 2 prospective clinical trials, including a total of 960 men who each had 1 injection of Ga 67 PSMA-11. In the 1st trial, men with positive readings in their pelvic lymph nodes on Ga 68 PSMA-11 PET had a clinically meaningful rate of metastatic cancer that was confirmed by surgical pathology.
The 2nd study involved patients with rising serus PSA levels after prostate surgery or radiotherapy. Nearly 3/4th (74%) had at least 1 positive cancer lesion detected by Ga 68 PSMA-11. Local recurrence or metastasis was confirmed in 91% of patients.
There were no major adverse events with Ga 68 PSMA-11. Common reactions included nausea, diarrhea and dizziness. Additionally, clinicians should be aware that there is a risk of misdiagnosis if the agent binds to non-alignment cells.
With this 1st approval of PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body.