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On May 27, 2021, Lantheus Holdings announced that the US FDA has approved the listing of Pylarify (piflufolastat F18), a positron emission tomography (PET) imaging agent, to identify suspected metastasis or recurrence of prostate cancer.
Pylarify's approval is based on data from two key studies, OSPREY and CONDOR, enrolling a total of 593 patients.
Among male patients with localized prostate cancer who received initial radical treatment, up to 50% of patients may have disease recurrence within 10 years after treatment.
Note: The original text has been deleted
Reference materials:
[1] Lantheus Receives US FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer.