The clear diagnostic edge you need

PYLARIFY delivers accurate detection without a high false-positive rate¹

¹⁸F has a longer half-life than ⁶⁸Ga, 110 minutes vs 68 minutes, which offers logistical advantages.^2-4

In comparison to ⁶⁸Ga-based PET imaging agents, ¹⁸F-based imaging agents, as a class, deliver better spatial resolution and less noise.³

See ¹⁸F Clarity

See ¹⁸F Detection Accuracy

While all PSMA PET imaging agents carry the risk of image misinterpretation, PYLARIFY has no additional specific warning for image misinterpretation in the prostate/prostate bed in patients with BCR in the Prescribing Information.¹

Making a clear difference for advanced PCa diagnostics

Patients with high-risk PCa who were candidates for initial definitive therapy

In the OSPREY study (COHORT A): PSMA-targeted PET scan with PYLARIFY significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV⁵:

See OSPREY Study (COHORT A) Data

Patients with recurrent PCa based on rising PSA after therapy

In the CONDOR study: PSMA-targeted PET scan with PYLARIFY achieved the primary endpoint of correct localization rate (CLR): 85%-87% across all 3 readers (lower bound of 95% CI: 78%-80%).¹ PYLARIFY CLR remained high regardless of which imaging modality was used as the standard of truth⁶:

See CONDOR Study Data

Patients with locally recurrent or new/progressive metastatic PCa with persistent elevated PSA level

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 plan⁵:

See OSPREY Study (COHORT B) Data

Video featuring Michael David Lutz, MD on the importance of PSMA PET imaging for treatment management

Michael David Lutz, MD, explains the benefits of PSMA PET imaging for prostate cancer diagnosis and initial staging.

BCR=biochemical recurrence; CI=confidence interval; NPV=negative predictive value; PCa=prostate cancer; PET=positron emission tomography; PPV=positive predictive value; PSA=prostate-specific antigen; 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

PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
Martiniova L, De Palatis L, Etchebehere E, Ravizzini G. Gallium-68 in medical imaging. Curr Radiopharm. 2016;9(3):187-207.
Werner RA, Derlin T, Lapa C, et al. ¹⁸F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics. 2020;10(1):1-16.
de Vries EFJ, Elsinga PH, Tsoumpas C. Will extended field-of-view PET/CT depopulate the graveyard of failed PET radiopharmaceuticals? Cancer Imaging. 2022;22(1):70.
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.
Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of ¹⁸F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. Clin Cancer Res. 2021;27(13):3674-3682.

The clear diagnostic edge you need

PYLARIFY delivers accurate detection without a high false-positive rate1

Making a clear difference for advanced PCa diagnostics

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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PYLARIFY delivers accurate detection without a high false-positive rate¹