Compared to standard imaging, PSMA-targeted PET scan with PYLARIFY delivered:

Significantly higher specificity (97.9% vs 65.1%)
Nearly 3 times the PPV (86.7% vs 28.3%)
Similar sensitivity to standard imaging

In a post-hoc analysis, PYLARIFY achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm¹

Sensitivity
Specificity
PPV
NPV

Median of 3 independent readers

Post-hoc analysis (Pelvic lymph nodes >5 mm)¹ n=225

Adapted from Pienta KJ, et al. In: J Urol. 2021.

60.0

(95% CI: 0.44, 0.76)

97.9

(95% CI: 0.95, 0.99)

84.6

(95% CI: 0.66, 0.94)

92.9

(95% CI: 0.89, 0.97)

Primary analysis (All pelvic lymph nodes)² n=252

Adapted from PYLARIFY® Prescribing Information. 2021.

38.0

(95% CI: 0.26, 0.51)

96.0

(95% CI: 0.94, 0.99)

77.0

(95% CI: 0.62, 0.92)

83.0

(95% CI: 0.78, 0.88)

In the pre-specified analysis, the specificity of co-primary endpoint with PSMA-targeted PET scan with PYLARIFY® was met (the lower limits of the 95% CIs for all readers were >80%), but the sensitivity co-primary endpoint was not met, in part due to limitations in PET/CT image resolution for tumors smaller than 5 mm^1,3,4
PSMA-targeted PET scan with PYLARIFY achieved high PPV (range: 72%-81%) and NPV (81%-84%), reducing the risk of undertreatment²

CI=confidence interval; CT=computed tomography; NPV=negative predictive value; 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.
PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
Crippa F, Leutner M, Belli F, et al. Which kinds of lymph node metastases can FDG PET detect? A clinical study in melanoma. J Nucl Med. 2000;41(9):1491-1494.
Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1-14.

Compared to standard imaging, PSMA-targeted PET scan with PYLARIFY delivered:

In a post-hoc analysis, PYLARIFY achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm1

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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In a post-hoc analysis, PYLARIFY achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm¹