Clear confidence and
consistency

Results from the CONDOR study support consistency in reader interpretation¹

In patients with recurrent prostate cancer based on elevated serum PSA, PSMA-targeted PET scan with PYLARIFY® achieved the primary endpoint of correct localization rate (CLR): 85% to 87% across all 3 readers (lower bound of 95% CI: 78% to 80%).²

This result significantly exceeds the threshold for the FDA-recommended endpoint, CLR. The threshold is defined as the lower bound of 95% CI >20% for at least 2 out of 3 readers.^1,2

	Reader 1	Reader 2	Reader 3
True positive	89	87	84
False positive	15	13	15
PET-positive without reference standard	33	24	24
PET-negative	71	84	85
CLR % (95% Cl)	86  (79, 92)	87  (80, 94)	85  (78, 92)

CLR was the location-matched positive predictive value in the Evaluable Set (true positive/[true positive + false positive])²

About Correct Localization Rate (CLR)

CLR is a measure of PPV enhanced with precise anatomical location of site disease.²

CLR is based on anatomical lesion matching, or co-localization, of lesions identified by PYLARIFY and lesions identified by the standard of truth (SOT)
The CLR was defined as the percentage of patients with a 1:1 correspondence between at least 1 lesion identified on PYLARIFY and on the SOT

Image of 'clear' male figure showing true positive rates

PYLARIFY Central Reader Findings

SOT Findings

CI=confidence interval; CT=computed tomography; FDA=US Food and Drug Administration; PET=positron emission tomography; PPV=positive predictive value; PSA=prostate-specific antigen; SOT=standard of truth.

About Correct Localization Rate (CLR)

CLR is a measure of PPV enhanced with precise anatomical location of site disease.²

CLR is based on anatomical lesion matching, or co-localization, of lesions identified by PYLARIFY and lesions identified by the standard of truth (SOT)
The CLR was defined as the percentage of patients with a 1:1 correspondence between at least 1 lesion identified on PYLARIFY and on the SOT

PYLARIFY Central Reader Findings

SOT Findings

PSMA-targeted PET scan with PYLARIFY achieved the primary endpoint of CLR: 85% to 87% across all 3 readers (lower bound of 95% CI: 78% to 80%)²

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. 2. 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.

Clear confidence and consistency

Results from the CONDOR study support consistency in reader interpretation1

About Correct Localization Rate (CLR)

About Correct Localization Rate (CLR)

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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Clear confidence and
consistency

Results from the CONDOR study support consistency in reader interpretation¹