PATIENTS WITH LOCALLY RECURRENT OR NEW/PROGRESSIVE METASTATIC PCa WITH PERSISTENT ELEVATED PSA LEVEL

PYLARIFY® PET/CT detected PSMA-positive lesions in 57.6% (19/33) of patients with recurrent prostate cancer and no evidence of distant metastases on conventional imaging²

11 of 19 patients underwent targeted biopsy and 10/11 (91%) were confirmed to have prostate cancer on pathology³
8 of 19 patients (42%) were not able to be biopsied³

In men post therapy with suspected recurrent or metastatic disease, PYLARIFY® PET/CT demonstrated high sensitivity and PPV in all sites of disease²

In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%- 99.0%) and 81.9% (73.7%- 90.2%), respectively²

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

REVIEW THE OSPREY CLINICAL TRIAL DESIGN (OSPREY COHORT B)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)

In Cohort B, OSPREY assessed sensitivity and PPV in men with radiologic evidence of recurrence

Clinical trial design for the Osprey trial

SEE EFFICACY DATA IN PATIENTS WITH

BIOCHEMICALLY
RECURRENT PCa

LEARN MORE

CT=computed tomography; MRI=magnetic resonance imaging; 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
Data on file. North Billerica, MA: Progenics Pharmaceuticals, Inc.; 2021.

PYLARIFY® PET/CT detected PSMA-positive lesions in 57.6% (19/33) of patients with recurrent prostate cancer and no evidence of distant metastases on conventional imaging2

In men post therapy with suspected recurrent or metastatic disease, PYLARIFY® PET/CT demonstrated high sensitivity and PPV in all sites of disease2

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)

SEE EFFICACY DATA IN PATIENTS WITH

BIOCHEMICALLY RECURRENT PCa

PYLARIFY® PET/CT detected PSMA-positive lesions in 57.6% (19/33) of patients with recurrent prostate cancer and no evidence of distant metastases on conventional imaging²

In men post therapy with suspected recurrent or metastatic disease, PYLARIFY® PET/CT demonstrated high sensitivity and PPV in all sites of disease²

BIOCHEMICALLY
RECURRENT PCa