When assessing patients with suspected prostate cancer metastasis who are candidates for
initial definitive therapy or suspected recurrence based on elevated PSA,

PYLARIFY® reveals The clearer Picture.^2-10

Not actual patients.

*Category 2A recommendations are made when based upon lower-level evidence there is uniform NCCN consensus that the intervention is appropriate.
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.

Clarify with PYLARIFY®

PET IMAGING:
FOR ACCURACY⁵
PSMA TARGETING:
FOR PRECISION^6-8
¹⁸F RADIOISOTOPE:
FOR CLARITY⁴
ARTIFICIAL INTELLIGENCE:
FOR CONSISTENCY¹

This combination brings superior diagnostic performance in assessing patients with suspected metastasis for initial definitive therapy^† or suspected recurrence based on elevated PSA,^‡ allowing you to better assess your patients' disease status.^2,4,5,9

^†Compared to standard anatomic images.¹²
^‡In the setting of negative or equivocal standard imaging.¹³

See PYLARIFY® data in patients with high-risk PCa who were candidates for initial definitive therapy

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See trial results in patients with biochemically recurrent prostate cancer

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Learn how
PYLARIFY® works

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Find a PYLARIFY® imaging center near you

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The incidence of prostate cancer is rising and
resulting mortality rates remain significant^14,15

Approximately 248,530 new prostate cancer cases will be diagnosed in 2021

new prostate cancer cases will be diagnosed in 2022^14,15

Approximately 34,130 PCa deaths will occur in 2021

deaths will occur in 2022 due to PCa, the second leading cause of cancer death in American men^14,15

Accurate initial assessment of a patient's disease is critical because high-risk PCa is more likely to be advanced at diagnosis and/or relapse than low-risk PCa^11,16,17

5-year relative survival rate for patients diagnosed with localized prostate cancer approaches 100%, however, if distant metastasis is present at the time of diagnosis, the 5-year survival rate has been reported to be 32%¹⁸

5-year survival rates of localized, regional, and distant prostate cancer

Standard imaging offers limited accuracy in PCa assessment, potentially compromising therapeutic decision-making^19,20

Although bone scans and CT scans can detect bone metastases, they lack sensitivity for early lesion detection⁵
Standard imaging offers limited utility in detecting recurrent lesions at PSA levels <1.0 ng/mL²¹
CT scans and MRIs depend on size to detect lesions, and are therefore less likely to detect metastatic tumors between 4 mm and 8 mm^5,12
Bone remodeling in response to treatment may lead to false positives on MRI images⁵

PET imaging^§ has the potential to improve disease localization compared to standard imaging, thus enhancing therapeutic decision-making^19,20,22

^§With an appropriate tracer and combined with CT or MRI.

PSMA PET/CT can detect lesions between 4 mm and 8 mm, and therefore has a higher detection rate^5,12
- Because up to 80% of nodal metastases in PCa are smaller than 8 mm in size, PSMA PET/CT is a promising imaging modality⁵
PSMA PET/CT is also effective at lower PSA levels; the rate of detection of nodal metastases has been reported to be 46% when PSA was <0.2 ng/mL⁵

PSMA PET IMAGING
IMPROVES DISEASE
ASSESSMENT

which reduces the risk of undertreatment (leading to disease spread) and overtreatment (leading to unnecessary toxicity or surgery)^23,24

LEARN ABOUT PYLARIFY®
FOR PCa IMAGING

CT=computed tomography; MRI=magnetic resonance imaging; NCCN=National Comprehensive Cancer Network; PCa=prostate cancer; PET=positron emission tomography; PSMA=prostate-specific membrane antigen.

PYLARIFY® for PCa Imaging

INDICATION & IMPORTANT
SAFETY INFORMATION

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.

INDICATION

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 1-800-332-10881-800-FDA-1088 or www.fda.gov/medwatch.

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

References

FDA clearance letter for aPROMISE X. Food and Drug Administration. April 29, 2022.
PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
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. doi:10.2967/jnumed.119.234799
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. doi:10.7150/thno.37894
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. doi:10.1177/1758835919876828
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):1-8. doi:10.1186/s40644-020-0290-9
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;296:44-55. doi:10.1148/radiol.2020191689
Ceci F, Fanti S. PSMA PET/CT imaging in prostate cancer: why and when. Clin Transl Imaging. 2019;7:377-379. doi:10.1007/s40336-019-00348-x
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. doi:10.1007/s11307-015-0866-0
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. doi:10.1007/s11307-015-0850-8
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer. V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed November 10, 2022. 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.
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. doi:10.1097/JU.0000000000001698
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. doi:10.1158/1078-0432.CCR-20-4573
Key statistics for prostate cancer. American Cancer Society. Updated January 12, 2022. Accessed November 21, 2022. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. doi:10.3322/caac.21708
Wang Z, Ni Y, Chen J, et al. The efficacy and safety of radical prostatectomy and radiotherapy in high-risk prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2020;18(1):42. doi:10.1186/s12957-020-01824-9
Chang AJ, Autio KA, Roach M 3rd, Scher HI. High-risk prostate cancer-classification and therapy. Nat Rev Clin Oncol. 2014;11(6):308-323. doi:10.1038/nrclinonc.2014.68
Cancer stat facts: prostate cancer. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed November 21, 2022. https://seer.cancer.gov/statfacts/html/prost.html
Hofman MS, Lawrentschuk N, Francis RJ, et al; proPSMA Study Group Collaborators. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395(10231):1208-1216. doi:10.1016/S0140-6736(20)30314-7
Rousseau E, Wilson D, Lacroix-Poisson F, et al. A prospective study on ¹⁸F-DCFPYL PSMA PET/CT imaging in biochemical recurrence of prostate cancer. J Nucl Med. 2019;60(11):1587-1593. doi:10.2967/jnumed.119.226381
Taneja SS. Imaging in the diagnosis and management of prostate cancer. Rev Urol. 2004;6(3):101-113.
Li R, Ravizzini GC, Gorin MA, et al. The use of PET/CT in prostate cancer. Prostate Cancer Prostatic Dis. 2018;21(1):4-21. doi:10.1038/s41391-017-0007-8
Park SY, Zacharias C, Harrison C, et al. Gallium 68 PSMA-11 PET/MR imaging in patients with intermediate- or high-risk prostate cancer. Radiology. 2018;288(2):495-505. doi:10.1148/radiol.2018172232
Gorin MA, Rowe SP, Patel HD, et al. Prostate specific membrane antigen targeted ¹⁸F-DCFPYL positron emission tomography/computerized tomography for the preoperative staging of high risk prostate cancer: results of a prospective, phase II, single center study. J Urol. 2018;199(1):126-132. doi:10.1016/j.juro.2017.07.070

When assessing patients with suspected prostate cancer metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated PSA,

PYLARIFY® reveals The clearer Picture.2-10

Clarify with PYLARIFY®

Accurate initial assessment of a patient's disease is critical because high-risk PCa is more likely to be advanced at diagnosis and/or relapse than low-risk PCa11,16,17

PET imaging§ has the potential to improve disease localization compared to standard imaging, thus enhancing therapeutic decision-making19,20,22

PSMA PET IMAGING IMPROVES DISEASE ASSESSMENT

When assessing patients with suspected prostate cancer metastasis who are candidates for
initial definitive therapy or suspected recurrence based on elevated PSA,

PYLARIFY® reveals The clearer Picture.^2-10

Accurate initial assessment of a patient's disease is critical because high-risk PCa is more likely to be advanced at diagnosis and/or relapse than low-risk PCa^11,16,17

PET imaging^§ has the potential to improve disease localization compared to standard imaging, thus enhancing therapeutic decision-making^19,20,22

PSMA PET IMAGING
IMPROVES DISEASE
ASSESSMENT