IN PATIENTS WITH HIGH-RISK PROSTATE CANCER WHO WERE CANDIDATES FOR INITIAL DEFINITIVE THERAPY,

PSMA PET with PYLARIFY® significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV²

In a post-hoc analysis, PYLARIFY® achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm²

Chart showing PYLARIFY® achieved high specificity, PPV, and NPV

In the pre-specified analysis, the specificity co-primary endpoint with PYLARIFY® (piflufolastat F 18) injection PET/CT 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^2,4,5
PYLARIFY® PET/CT achieved high PPV (range: 72%-81%) and NPV (81%-84%), reducing the risk of undertreatment³

In the CONDOR trial, 78.6% of changes to patients' treatment plans were based on positive PYLARIFY® PET/CT findings

Informed Decision-making

Following PYLARIFY® PET/CT imaging, 27% of patients for whom standard imaging showed only localized disease were revealed to have N1 or M1 disease after PSMA PET with PYLARIFY®.* This upstaging of disease may have a substantial impact on treatment management decisions.⁶*

*Change in treatment plan was not an endpoint in OSPREY. Future studies will be necessary to demonstrate whether PYLARIFY® PET/CT-directed changes in management lead to improved outcomes.²

PYLARIFY® achieved high PPV, specificity, and NPV compared to standard imaging while maintaining comparable sensitivity²

PYLARIFY® PET/CT specificity was significantly higher than with standard imaging (97.9% vs 65.1%)
PYLARIFY® PET/CT nearly tripled the PPV compared to standard imaging (86.7% vs 28.3%)
PYLARIFY® PET/CT achieved similar sensitivity to standard imaging

Review the OSPREY clinical trial design (OSPREY Cohort A)²

OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence (Cohort B; n=117)

OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT

Clinical trial design for the Osprey trial

In Cohort A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores^†

^†n=268; except for Distant Metastases (n=266) and Median PSA (n=267).
^‡Stage at time of study entry or most recent prior to entry.

PYLARIFY® PET/CT's HIGH PPV AND NPV RATES INDICATE THAT A

POSITIVE OR NEGATIVE RESULT FOR NODAL DISEASE IS MORE INFORMATIVE THAN STANDARD IMAGING,

allowing physicians to treat with more confidence²

REVIEW CASE STUDIES FROM PYLARIFY® CLINICAL TRIALS

CI=confidence interval; PLND=pelvic lymph node dissection; CT=computed tomography; NPV=negative predictive value; PCa=prostate cancer; PET=positron emission tomography; PPV=positive predictive value; PSA=prostate-specific antigen; PSMA=prostate-specific membrane antigen.

PYLARIFY® for PCa Imaging Case Studies

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.
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
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. doi:10.1177/1758835919876828
Carroll PR, Probst S, Rowe SP, et al. Changes to initial risk assessment and intended patient management in high-risk prostate cancer: an exploratory analysis of cohort A from the OSPREY trial. J Urol. 2021;206(suppl 3):e181-e182.

PSMA PET with PYLARIFY® significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV2

In a post-hoc analysis, PYLARIFY® achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm2

PYLARIFY® achieved high PPV, specificity, and NPV compared to standard imaging while maintaining comparable sensitivity2

OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence (Cohort B; n=117)

In Cohort A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores†

PYLARIFY® PET/CT's HIGH PPV AND NPV RATES INDICATE THAT A

POSITIVE OR NEGATIVE RESULT FOR NODAL DISEASE IS MORE INFORMATIVE THAN STANDARD IMAGING,

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PSMA PET with PYLARIFY® significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV²

In a post-hoc analysis, PYLARIFY® achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm²

PYLARIFY® achieved high PPV, specificity, and NPV compared to standard imaging while maintaining comparable sensitivity²

In Cohort A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores^†

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