PYLARIFY PET/CT combines the accuracy of PET imaging, the precision of PSMA targeting, and the clarity of an ¹⁸F radioisotope^1-8

PYLARIFY® (piflufolastat F 18) injection is 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

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Piflufolastat F 18 Injection (PYLARIFY) is
National Comprehensive Cancer Network®
(NCCN®) Recommended (Category 2A*)⁹

NCCN recommends piflufolastat F 18 Injection (PYLARIFY) as an alternative to standard imaging of bone and soft tissue for:

Initial risk stratification for certain patients with localized PCa
Detection of BCR disease after radical prostatectomy (preferred to conventional imaging)
Detection of BCR disease after radiation therapy (preferred to conventional imaging)
As workup for progression

Although the FDA has approved Ga-68 PSMA-11 for use with Lu-177–PSMA-617, the panel believes that F-18 piflufolastat PSMA and F-18 flotufolastat PSMA can also be used in the same space due to multiple reports describing the equivalency of these imaging agents.

—NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.3.2024

Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (CT, MRI) 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 front-line imaging tool for these patients.

—NCCN Guidelines® for Prostate Cancer

NCCN is generally consistent with SNMMI Appropriate Use Criteria

According to SNMMI Criteria, piflufolastat F 18 (PYLARIFY) is appropriate for¹⁰:

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

NCCN=National Comprehensive Cancer Network® (NCCN®)
*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.

Targeting PSMA enables PYLARIFY PET/CT to improve disease assessment in prostate cancer—even when PSA levels are low^11,12†

PSMA is a validated molecular target for PCa; it is overexpressed in >90% of tumor cells⁶

PSMA levels have a high prognostic value; higher PSMA expression is associated with higher Gleason score and lower survival rates¹³

^†PSA <2 ng/mL.

PYLARIFY is an ¹⁸F-labeled diagnostic imaging agent for PET that targets PSMA¹⁴

PYLARIFY binds to the active extracellular site of a PSMA molecule with high affinity, enabling the visualization of PCa cells rather than surrounding normal cells^1,4-6,14

PYLARIFY uses ¹⁸F to bring greater clarity and convenience to PET/CT imaging^2,7,15

As demonstrated in a head-to-head analysis, PET with ¹⁸F provides superior clarity compared to ⁶⁸Ga because of the lower endpoint positron energy emission, which results in a shorter distance traveled by positrons prior to annihilation.¹⁵

Positron energy spectrum for the decay of ⁶⁸Ga and ¹⁸F

Monte Carlo simulation of different positron tracks from the decay of ⁶⁸Ga and ¹⁸F in human lung and soft tissues

PET/CT with ¹⁸F has higher sensitivity and better resolution than PET/CT with ⁶⁸Ga, potentially facilitating more accurate interpretation and reporting of disease assessment¹⁵
¹⁸F has a longer half-life than ⁶⁸Ga (110 minutes versus 68 minutes), allowing for more widespread availability as well as more convenient and flexible scheduling for patients and staff^2,16

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

Learn more

¹⁸F=radioisotope fluorine-18; ⁶⁸Ga=radioisotope gallium-68; BCR=biochemically recurrent disease; CRPC=castration-resistant prostate cancer; CT=computed tomography; MRI=magnetic resonance imaging; NCCN=National Comprehensive Cancer Network; SNMMI=Society of Nuclear Medicine and Molecular Imaging; PCa=prostate cancer; PET=positron emission tomography; PSMA=prostate-specific membrane antigen.

Home Efficacy and Safety

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.

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.

INDICATION

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

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

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.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 18, 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 June 1, 2022. https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=38657.
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
Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol. 2018;8:623. doi:10.3389/fonc.2018.00623
PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
Sanchez-Crespo A. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission tomography. Appl Radiat Isot. 2013;76:55-62. doi:10.1016/j.apradiso.2012.06.034
Martiniova L, Palatis L, Etchebehere E, Ravizzini G. Gallium-68 in medical imaging. Curr Radiopharm. 2016;9(3):187-207. doi:10.2174/1874471009666161028150654

PYLARIFY PET/CT combines the accuracy of PET imaging, the precision of PSMA targeting, and the clarity of an 18F radioisotope1-8

Piflufolastat F 18 Injection (PYLARIFY) is National Comprehensive Cancer Network® (NCCN®) Recommended (Category 2A*)9

NCCN is generally consistent with SNMMI Appropriate Use Criteria

Targeting PSMA enables PYLARIFY PET/CT to improve disease assessment in prostate cancer—even when PSA levels are low11,12†

PYLARIFY is an 18F-labeled diagnostic imaging agent for PET that targets PSMA14

PYLARIFY uses 18F to bring greater clarity and convenience to PET/CT imaging2,7,15

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PYLARIFY PET/CT combines the accuracy of PET imaging, the precision of PSMA targeting, and the clarity of an ¹⁸F radioisotope^1-8

Piflufolastat F 18 Injection (PYLARIFY) is
National Comprehensive Cancer Network®
(NCCN®) Recommended (Category 2A*)⁹

Targeting PSMA enables PYLARIFY PET/CT to improve disease assessment in prostate cancer—even when PSA levels are low^11,12†

PYLARIFY is an ¹⁸F-labeled diagnostic imaging agent for PET that targets PSMA¹⁴

PYLARIFY uses ¹⁸F to bring greater clarity and convenience to PET/CT imaging^2,7,15

This link will take you to another
website not owned by Lantheus