How appropriate use criteria was created for PSMA-PET imaging

Patients with high-risk disease were shown to have a significantly higher mean value of SUVmax compared with patients with low-risk disease (23.5 ± 13.2 vs 10.6 ± 5.4; P < 0.05).

"We're excited that the FDA approval of this radiotracer gives us yet more tools at our disposal to diagnose prostate cancer in all its forms, from early to late in the disease process," says David M. Schuster, MD, FACR.

“If approved by the FDA, this new product will have a significant impact on prostate cancer patients, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA-PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care, and increasing the probability of patients’ survival," says Mike Crosby.

The phase 2/3 AlphaBreak trial is evaluating the safety and efficacy of FPI-2265 in patients with mCRPC who have been previously treated with 177Lu-PSMA radiotherapy.

"This was a very special moment, delivering the news to this patient that his cancer is now undetectable following the treatment with 2 doses of 8 GBq of 67Cu-SAR-bisPSMA," says Luke Nordquist, MD, FACP.

A late phase 3 trial evaluating the agent is underway at several clinics in Europe.