PYLARIFY® PET/CT Case Studies

In patients with high-risk PCa who were candidates for initial definitive therapy, PYLARIFY® PET/CT identified extra-pelvic lesions in 12.3% of patients, which were not detected with standard imaging²

Anterior and posterior diagnostic images of the human body

Bone Scan

Anterior and posterior diagnostic images of the human pelvis showing pelvic lesions

PET Image with PYLARIFY®

A patient in OSPREY with baseline staging T1c N0 M0, PSA 13.68 ng/mL, and Gleason score 4+5. CT imaging (not shown) showed no evidence of metastatic disease, and bone scintigraphy showed changes of left hip arthroplasty and increased tracer uptake in the anterior superior iliac spine (shown with arrow), but otherwise normal. PYLARIFY® (piflufolastat F 18) injection showed multifocal osseous lesions on the spine, ribs, pelvis, and right clavicle. Biopsy of left transverse process of L3 confirmed osseous metastatic disease (M1b).²

In CONDOR, across the 3 readers, PYLARIFY® detected at least 1 previously occult lesion in 59.6%-65.9% of patients^3,4

Diagnostic images from the Condor Trial showing abdominal lesions in the human body

PYLARIFY® PET scan revealing that a 71-year-old patient had left common iliac lesions and multiple lymph node lesions

71-year-old patient had a Gleason score of 4+3, history of radical prostatectomy, EBRT with PSA 1.92 ng/mL, and equivocal results on ¹⁸F fluciclovine PET/CT scan
PYLARIFY® showed left common iliac lesions and multiple retroperitoneal para/peri aortic lymph node lesions
Biopsy of retroperitoneal lymph node confirmed prostate cancer

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CT=computed tomography; EBRT=external beam radiation therapy; GnRH=gonadotropin-releasing hormone; MRI=magnetic resonance imaging; PCa=prostate cancer; PET=positron emission tomography; PSA=prostate-specific antigen.

Efficacy and Safety How to Use PYLARIFY®

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
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
Data on file. New York, NY: Progenics Pharmaceuticals, Inc.; 2021.

PYLARIFY® PET/CT Case Studies

In patients with high-risk PCa who were candidates for initial definitive therapy, PYLARIFY® PET/CT identified extra-pelvic lesions in 12.3% of patients, which were not detected with standard imaging2

In CONDOR, across the 3 readers, PYLARIFY® detected at least 1 previously occult lesion in 59.6%-65.9% of patients3,4

SEE SAFETY DATA FOR PYLARIFY®

In patients with high-risk PCa who were candidates for initial definitive therapy, PYLARIFY® PET/CT identified extra-pelvic lesions in 12.3% of patients, which were not detected with standard imaging²

In CONDOR, across the 3 readers, PYLARIFY® detected at least 1 previously occult lesion in 59.6%-65.9% of patients^3,4

SEE SAFETY DATA
FOR PYLARIFY®