In the OSPREY study (COHORT B):

PSMA-targeted PET scan with PYLARIFY® detected PSMA-positive lesions in 57.6% (19/33) of patients with no evidence of distant metastases on standard imaging, upstaging their disease and informing their treatment plan¹

11 of 19 patients underwent targeted biopsy and 10/11 (91%) were confirmed to have prostate cancer on pathology²
8 of 19 patients (42%) were not able to be biopsied²

In patients post therapy with suspected recurrent or metastatic disease, PSMA-targeted PET scan with PYLARIFY demonstrated high sensitivity and PPV in all sites of disease¹

In COHORT B (93 evaluable patients, median prostate-specific antigen 11.3 ng/mL), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%) respectively¹

Sensitivity
PPV

95.8

(0.88, 0.99)

81.9

(0.74, 0.90)

96.8

(0.82, 1.0)

81.6

(0.69, 0.94)

96.7

(0.82, 1.0)

(0.68, 0.94)

100

(0.66, 1.0)

(0.57, 1.0)

Percentage

Overall

n=93

Bone

n=43

n=44

Lymph Nodes

n=39

Visceral/ Soft Tissues

n=10

CT=computed tomography; PET=positron emission tomography; PPV=positive predictive value; PSMA=prostate-specific membrane antigen.

INDICATION

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent 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.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-26681-80‌0-36‌2-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

References

Pienta KJ, Gorin MA, Rowe SP, et al. A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with ¹⁸F-DCFPyL in prostate cancer patients (OSPREY). J Urol. 2021;206(1):52-61. 2. Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2024.

In the OSPREY study (COHORT B):

In patients post therapy with suspected recurrent or metastatic disease, PSMA-targeted PET scan with PYLARIFY demonstrated high sensitivity and PPV in all sites of disease1

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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In patients post therapy with suspected recurrent or metastatic disease, PSMA-targeted PET scan with PYLARIFY demonstrated high sensitivity and PPV in all sites of disease¹