Piflufolastat F 18

(Pylarify®)

Pylarify®

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Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 37 MBq/ mL to 2,960 MBq/mL [1 mCi/mL to 80 mCi/mL])
Drug ClassRadioactive diagnostic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy.
  • Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Summary
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  • Piflufolastat F 18 (Pylarify) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen positive lesions in men with prostate cancer who are candidates for initial definitive therapy or have suspected recurrence based on elevated serum PSA levels.
  • The study compares the effectiveness and safety of Pylarify to another PET/CT tracer, fluoromethylcholine.
  • In terms of effectiveness, the detection rate was significantly higher for Pylarify than for fluoromethylcholine (58% vs 40%), encompassing a broad PSA range. For instance, the detection rate for PSA levels >2.0 ng/ml was 88% versus 68%, respectively.
  • Regarding the impact on patient management, changes post-PET/CT scans occurred in more cases with Pylarify compared to fluoromethylcholine (44% against 29%), suggesting its clinical utility not only in detection but also in influencing treatment pathways.
  • From a safety perspective, no drug-related or serious adverse events were reported during the study, indicating that Piflufolastat F 18 has an excellent safety profile, making it a safe option for patients undergoing PET/CT scans.
  • The study specifically enrolled participants experiencing their first biochemical recurrence after radical prostatectomy or radiation therapy, providing insight into this particular subgroup within the broader population suffering from prostate cancer.

Product Monograph / Prescribing Information

Document TitleYearSource
Pylarify (piflufolastat F 18) Prescribing Information.2023Progenics Pharmaceuticals, Inc., Billerica, MA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
[18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in biochemical recurrence of prostate cancer (PYTHON): a prospective, open label, cross-over, comparative study.
141Subjects
F: 0%
M: 100%
2023European Journal of Nuclear Medicine and Molecular Imaging

Sex Distribution:

F:0%
M:100%
141Subjects

Year:

2023

Source:European Journal of Nuclear Medicine and Molecular Imaging