FDA Approves 18F-DCFPyL PSMA-PET imaging!
Well, we’ve been talking about this for many months and now it’s history — PyL PSMA-PET scanning is now FDA approved for two types of prostate cancer patients, i.e., those with newly diagnosed high-risk disease who are suspect for metastasis; and those patients with recurrent disease that have a rising PSA after primary therapy has failed. So this includes most of the men in AnCan’s High Risk/Recurrent/Advanced group which meets every week on alternating Mondays and Tuesdays.
Unlike the previous 68Ga-PSMA-11 scan approved in December of 2020, the PyL scan has a longer shelf life and therefore it can be commercially produced and shipped to any medical facility that is capable of performing PET imaging. One caveat, however, is that it may take Medicare several months before they will approve reimbursement for this scan.
The actual drug approved by the FDA is Pylarify made by Lantheus Holdings. It carries the radionuclide to the prostate cell so it can be seen and scanned.