Image of actor portrayals for actual case studies (patients with recurrence based on rising PSA after therapy)

Comparative case study

Patients with BCR post-RP

Actor portrayals for actual case studies.

Patient A

Age

PSA (ng/mL)

0.8

Gleason
Score

3 + 4

Stage

pT2N0M0

Patient B

Age

PSA (ng/mL)

0.9

Gleason
Score

3 + 4

Stage

pT2bN0M0

In patients with similar profiles, PYLARIFY identified differences in extent of disease,

guiding treatment changes.

PET scan image of the male body pointing out the peri-rectal lymph node

Courtesy (with permission) from Gary Ulaner, MD, PhD, FACNM, Hoag Family Cancer Institute.

Post-PYLARIFY® treatment decisions

Patient A

Treatment change from EBRT to pelvis with additional boost to prostatic fossa, to lesion-specific SBRT
Post-treatment PSA levels dropped to 0.06 ng/mL

Patient B

Treatment with IMRT to lymph nodes + ADT
Post-radiation PSA levels dropped to 0.04 ng/mL

ADT=androgen deprivation therapy; BCR=biochemical recurrence; EBRT=external beam radiation therapy; IMRT=intensity-modulated radiation therapy; MIP=maximum intensity projection; PET=positron emission tomography; PSA=prostate-specific antigen; RP=radical prostatectomy; SBRT=stereotactic body radiation therapy.

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.

Patients with BCR post-RP

Patient A

Patient B

In patients with similar profiles, PYLARIFY identified differences in extent of disease,

Post-PYLARIFY® treatment decisions

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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