Explore the CONDOR Study on PYLARIFY®

PYLARIFY CLR remained high regardless of which modality was used as the standard of truth¹:

Correlative imaging

¹⁸F fluciclovine PET/CT (n=71): 86.8%-90.9% across all 3 readers
MRI (n=23): 80.0%-86.7% across all 3 readers
CT (n=6): 80.0%-100% across all 3 readers

Histopathology²

78.6% to 82.8% (n=31) across all 3 readers

PYLARIFY PET/CT demonstrated high CLR independent of baseline PSA levels¹

CLR by Baseline PSA

Reader 1
Reader 2
Reader 3

73.3

(51.0, 95.7)

75.0

(53.8, 96.2)

83.3

(66.1, 100)

91.3

(79.8, 100)

96.4

(89.6, 100)

Percentage

<0.5

n=15

0.5-<1.0

n=16

1.0-<2.0

n=18

2.0-<5.0

n=23

≥5.0

n=28

Baseline PSA levels (ng/mL)

The success criteria for CLR was achieved in CONDOR: The lower bounds of the 95% CIs for CLR were >20% across all 3 readers

Detection rates for PYLARIFY PET/CT rose with increasing PSA levels

(36.2% at <0.5 ng/mL to 96.7% at ≥5 ng/mL)¹

Reader 1
Reader 2
Reader 3

36.2

(24.9, 47.6)

51.4

(35.2, 67.5)

66.7

(50.6, 82.8)

84.8

(72.6, 97.1)

96.7

(92.2, 100)

Percentage

<0.5

n=69

0.5-<1.0

n=37

1.0-<2.0

n=33

2.0-<5.0

n=33

≥5.0

n=30

Baseline PSA levels (ng/mL)

CI=confidence interval; CLR=correct localization rate; CT=computed tomography; MRI=magnetic resonance imaging; PET=positron emission tomography; PSA=prostate-specific antigen

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

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.
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. Supplementary Appendix. Clin Cancer Res. 2021;27(13):3674-3682.

PYLARIFY CLR remained high regardless of which modality was used as the standard of truth1:

PYLARIFY PET/CT demonstrated high CLR independent of baseline PSA levels1

Detection rates for PYLARIFY PET/CT rose with increasing PSA levels

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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PYLARIFY CLR remained high regardless of which modality was used as the standard of truth¹:

PYLARIFY PET/CT demonstrated high CLR independent of baseline PSA levels¹