Clear action for intended patient management

PYLARIFY has robust clinical data to show the full picture¹

Data for change in intended treatment are based on

99% graphic

of enrolled patients in the pivotal CONDOR study^1,2*

2 out of 3 men icon

In patients with BCR, nearly 2 out of 3 patients who underwent PSMA PET imaging with PYLARIFY® after negative or uninformative standard imaging had a change in intended disease management based on findings on the PYLARIFY scan.¹ Change in management may prevent undertreatment or overtreatment.^†

^†Future studies would be necessary to demonstrate whether PYLARIFY PET/CT-directed changes in management lead to improved outcomes for patients with prostate cancer.¹

*The Phase 3 pivotal trial for PYLARIFY (CONDOR) evaluated change in intended management as a secondary endpoint and demonstrated nearly 2/3 of patients had a change in intended management recommendation following PYLARIFY PSMA PET.¹

Video featuring James Gray, MD on how PYLARIFY has helped change his approach on patient management

James Gray, MD, shares how PYLARIFY has helped change his approach to patient management.

PYLARIFY can help inform and guide intended treatment

PYLARIFY helped change the course of intended treatment for the majority of patients with BCR^1*

(131/205) of patients with noninformative standard imaging^† had a change in intended management plan^1*

(103/131) of the changes were based on positive PSMA-targeted scan with PYLARIFY findings¹

(28/131) of the changes were based on negative PSMA-targeted scan with PYLARIFY findings¹

Video featuring Michael David Lutz, MD on the benefits of PSMA PET imaging for prostate cancer diagnosis and initial staging

Michael David Lutz, MD, highlights the importance of PSMA PET imaging for treatment management.

Following PYLARIFY imaging results, the most frequent changes to treatment management plans were (N=205)¹:

Salvage local therapy

Systemic therapy

(n=58; 28.3%)

Systemic therapy

Salvage local therapy

(n=43; 21.0%)

Observation

Initiating therapy

(n=49; 23.9%)

Planned treatment

Observation

(n=9; 4.4%)

In patients with baseline PSA <0.5 ng/mL, 39% had a unidirectional change in planned management.³

*Change in treatment plan was a secondary endpoint in CONDOR. Future studies will be necessary to demonstrate whether PSMA-targeted PET scan with PYLARIFY-directed changes in management lead to improved outcomes for patients with prostate cancer.¹

Video featuring Ben Lowentritt, MD, FACS, on scenarios where PSMA PET imaging changed the course of patient care

Ben Lowentritt, MD, FACS, recounts scenarios where PSMA PET imaging changed the course of patient care.

BCR=biochemical recurrence; CT=computed tomography; PET=positron emission tomography; PSA=prostate-specific antigen; PSMA=prostate-specific membrane antigen.
^†Standard imaging included CT/MRI/bone scan and ¹⁸F fluciclovine.¹

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.
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(suppl3):e181-e182.
Pouliot F, Gorin MA, Rowe SP, et al. Changes in planned disease management after piflufolastat F 18 PET/CT in men with biochemically recurrent prostate cancer and low PSA levels: A secondary analysis of results from the CONDOR study. Poster presented at: 2023 ASCO Genitourinary Cancers Symposium; February 16-18. Abstract ID: 61.

Clear action for intended patient management

PYLARIFY has robust clinical data to show the full picture1

PYLARIFY can help inform and guide intended treatment

PYLARIFY helped change the course of intended treatment for the majority of patients with BCR1*

Following PYLARIFY imaging results, the most frequent changes to treatment management plans were (N=205)1:

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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PYLARIFY has robust clinical data to show the full picture¹

PYLARIFY helped change the course of intended treatment for the majority of patients with BCR^1*

Following PYLARIFY imaging results, the most frequent changes to treatment management plans were (N=205)¹: