Progenics Pharmaceuticals Inc. said its imaging agent PyL helped in localizing tumors in prostate cancer patients with biological recurrence of the disease in a late-stage study.
Localization of cancer is the process of determining the location of the disease or keeping the disease in a specific location. Biological recurrence is when the disease comes back after treatment with surgery or radiation, even when patients do not suffer from symptoms.
The New York-based biotechnology company said that PyL, or 18F-DCFPyL, achieved the main goal of the study, dubbed Condor, with a correct localization rate of 84.8% to 87% in the 208 patients enrolled in the trial by using three blinded independent readers. The agents helped in localizing at least one lesion.
In addition, the company said PyL was well-tolerated in patients, consistent with the phase 2 Osprey study results. However, one patient suffered from hypersensitivity while four patients experienced headaches.
Progenics said it plans to file an application with the U.S. Food and Drug Administration in the second half of 2020 for the approval of the agent. Detailed results of the study will be presented at an upcoming medical meeting.
According to the company's Dec. 23 press release, prostate cancer is the second-most common form of cancer affecting men in the U.S. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease.