As the #1 utilized PSMA PET imaging agent in the US, PYLARIFY is the clear standard in PSMA PET²

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Learn how PYLARIFY® has made a difference for patients with metastatic prostate cancer (PCa)

PYLARIFY for accuracy, precision, and clarity

PYLARIFY combines the accuracy of PET imaging, the precision of PSMA targeting, and the clarity of an ¹⁸F radioisotope.^3-10

PYLARIFY (piflufolastat F 18) Injection is indicated for 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 (PSA) level

PYLARIFY targets PSMA—helping to improve disease assessment in prostate cancer—even when PSA levels are low.^11,12

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Supported in major clinical guidelines

National Comprehensive Cancer Network® (NCCN®)

According to NCCN, PSMA-PET/CT or PET/MRI can be considered as an alternative to standard imaging of bone and soft tissue for¹³:

Initial staging
Detection of biochemically recurrent disease
As workup for progression

❝Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (eg, CT, bone scan) at both initial staging and biochemical recurrence, the [NCCN] panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as an equally effective, if not more effective frontline imaging tool for these patients.❞

Society of Nuclear Medicine & Molecular Imaging (SNMMI)

The SNMMI Appropriate Use Criteria are Generally Consistent with the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)¹⁴

According to SNMMI Appropriate Use Criteria, PSMA PET with PYLARIFY is appropriate for:

Men with newly diagnosed unfavorable intermediate-, high-, or very-high-risk PCa
Men with BCR after radical prostatectomy or radiation therapy
Men with CRPC shown to be M0 on standard imaging
Evaluation of eligibility for patients being considered for PSMA-targeted radioligand therapy

American Urological Association (AUA)

According to the AUA and Society of Urologic Oncology (SUO)¹⁵:

For BCR without metastatic disease after exhaustion of local treatment options:

❝Both ⁶⁸Ga-PSMA-11 and ¹⁸F-DCFPyl are indicated for patients with suspected prostate cancer metastasis considering surgery or radiation therapy and also indicated for patients with suspected prostate cancer recurrence based on elevated serum PSA levels.❞

—Guideline Statement, AUA/SUO¹⁵

❝Clinicians should utilize PSMA PET imaging preferentially, where available, in patients with PSA recurrence after failure of local therapy as an alternative to conventional imaging due to its greater sensitivity, or in the setting of negative conventional imaging.❞

—Expert Opinion, AUA/SUO¹⁵

❝The availability of PSMA PET, which detects metastatic disease at low PSA values, is increasing in the US.❞

—Expert Opinion, AUA/SUO¹⁵

The suggested interval for imaging is 6 to 12 months, with the exact interval determined by the PSADT calculation, the development of symptoms, and patient/physician preference.¹⁵

Video featuring Tom Boike, MD, MMM on the limitations of conventional imaging for prostate cancer compared to the advances of PSMA PET imaging

Tom Boike, MD, MMM, discusses the limitations of conventional imaging for prostate cancer compared to the advances of PSMA PET imaging.

BCR=biochemical recurrence; CRPC=castration-resistant prostate cancer; CT=computed tomography; MRI=magnetic resonance imaging; PCa=prostate cancer; PET=positron emission tomography; PSA=prostate-specific antigen; PSADT=PSA doubling time.

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.
Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2024.
Mena E, Lindenberg ML, Turkbey IB, et al. ¹⁸F-DCFPyL PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. J Nucl Med. 2020;61(6):881-889.
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.
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.
Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):10.
Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus ¹⁸F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296(1):44-55.
Ceci F, Fanti S. PSMA-PET/CT imaging in prostate cancer: why and when. Clin Transl Imaging. 2019;7:377-379.
Dietlein M, Kobe C, Kuhnert G, et al. Comparison of [¹⁸F]DCFPyL and [⁶⁸Ga]Ga-PSMA-HBED-CC for PSMA-PET imaging in patients with relapsed prostate cancer. Mol Imaging Biol. 2015;17(4):575-584.
Szabo Z, Mena E, Rowe SP, et al. Initial evaluation of [¹⁸F]DCFPyL for prostate-specific membrane antigen (PSMA)-targeted PET imaging of prostate cancer. Mol Imaging Biol. 2015;17(4):565-574.
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.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 22, 2024. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging. Society of Nuclear Medicine & Molecular Imaging. Updated March 2022. Accessed August 8, 2024. https://snmmi.org/Web/Clinical-Practice/Appropriate-Use-Criteria/Articles/Appropriate-Use-Criteria-for-Prostate-Specific-Membrane-Antigen--PSMA--PET-Imaging.
Lowrance W, Dreicer R, Jarrard DF, et al. Updates to advanced prostate cancer: AUA/SUO guideline (2023). J Urol. 2023;209(6):1082-1090.

As the #1 utilized PSMA PET imaging agent in the US, PYLARIFY is the clear standard in PSMA PET2

PYLARIFY for accuracy, precision, and clarity

PYLARIFY is an 18F-labeled imaging agent for PET that targets PSMA1

Supported in major clinical guidelines

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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As the #1 utilized PSMA PET imaging agent in the US, PYLARIFY is the clear standard in PSMA PET²

PYLARIFY is an ¹⁸F-labeled imaging agent for PET that targets PSMA¹