PYLARIFY is well tolerated

Across multiple studies, PYLARIFY was well-tolerated, with no individual adverse reaction occurring in more than 2% of patients¹

Adverse reactions that occurred in >0.5% of patients who received PYLARIFY® (N=593)^*

Adverse Reaction	n (%)
Headache	13 (2.0%)
Dysgeusia	10 (2.0%)
Fatigue	7 (1.0%)

*In addition, a hypersensitivity reaction was reported in 1 patient (0.2%) with a history of allergic reactions.

Clinical Trial Design:

OSPREY COHORT A²

OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 patients with either high-risk prostate cancer (COHORT A; n=268) or radiologic evidence of recurrence (COHORT B; n=117)

OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PSMA-targeted PET scan with PYLARIFY

Patient Population

268 patients with high-risk PCa (clinical stage ≥T3a, PSA >20 ng/mL, or Gleason score ≥8 with planned RP-PLND)

PSMA-targeted PET scan with PYLARIFY

A single dose of PYLARIFY 9 mCi (333 MBq) IV, followed by PET/CT after 1-2 hours

Evaluation

252 patients underwent surgery and had PLND evaluated locally by pathologists blinded to the imaging results. 16 patients did not undergo RP-PLND

Co-primary endpoints:

Specificity
Sensitivity

Secondary endpoints:

PPV
Detection of M1 disease
NPV
Detection of primary tumor within the prostate

In COHORT A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores^†

Median age (range)
65 (46-84)
Race and ethnicity
White	86.9%
Black or African American	8.6%
Hispanic	4.1%
Asian	2.6%
Other	0.7%
Regional lymph node (N) stage, AJCC^‡
NX	38.4%
N0	58.2%
N1	3.4%

Primary tumor (T) stage, AJCC^‡
TX	3%
T1a	0.4%
T1b	0.7%
T1c	32.5%
T2	2.6%
T2a	16.8%
T2b	11.2%
T2c	5.2%
T3	1.1%
T3a	20.9%
T3b	5.2%
T4	0.4%

Distance metastases (M) stage, AJCC^‡
Mx	17.9%
MO	80.6%
M1	0.4%
M1a	0%
M1b	0.4%
M1c	0%
Median PSA (ng/mL), (range)
9.7 (1.2-125.3)
Total Gleason score
6	1.1%
7	18.3%
8	44.8%
9	34.3%
10	1.5%

^†n=268; except for Distant Metastases (n=266) and Median PSA (n=267).

^‡Stage at time of study entry or most recent prior to entry.

AJCC=American Joint Commission on Cancer; CT=computed tomography; NPV=negative predictive value; PCa=prostate cancer; PET=positron emission tomography; PLND=pelvic lymph node dissection; PPV=positive predictive value; PSA=prostate-specific antigen; RP-PLND=radical prostatectomy and pelvic lymph node dissection.

Clinical Trial Design:

CONDOR³

CONDOR was a robust, multicenter, phase 3 trial of 208 patients with suspected recurrent or metastatic prostate cancer with negative or equivocal results using standard imaging

CONDOR assessed correct localization rate (CLR)—an improved metric for evaluating diagnostic performance compared to PPV—in patients with biochemically recurrent prostate cancer

Patient Population

208 patients with biochemically recurrent prostate cancer previously treated with radical prostatectomy and/or radiation therapy. All patients had negative/equivocal findings for prostate cancer on standard imaging 60 days before receiving PYLARIFY

PSMA-targeted PET scan with PYLARIFY

A single dose of PYLARIFY 9 mCi (333 MBq) IV 1-2 hours before PET/CT

Evaluation

Primary endpoint:

CLR of PYLARIFY

Secondary endpoint:

Percentage of patients with a change in intended treatment plan

For patients treated with RP, BCR was defined as a rising PSA to ≥0.2 ng/mL

For patients treated with RT, BCR was defined as a PSA value ≥2 ng/mL above patient’s post-radiation nadir value

Reference standards of truth in CONDOR

Because most patients were not expected to have an amenable lesion for histological verification, a composite standard of truth was discussed with the FDA based on these reference standards (in order of priority):

Evaluable histopathology results from prostatectomy, salvage pelvic lymph node dissection, or targeted biopsy
Correlative follow-up imaging findings using ¹⁸F-fluciclovine or ¹¹C-choline PET, or focused MRI or CT
If neither of the above was available or informative, confirmed PSA response^§ up to 9 months post-radiation initiation (without concomitant ADT) of all PET-positive foci

^§PSA response was defined as PSA decline by ≥50% from baseline that was confirmed on repeat measurement within 4 weeks, based on central laboratory results.

CONDOR included patients with a broad range of PSA levels and Gleason scores^†

Median age (range)
68 (43-91)
Patients ≥65 years old
67.8%
Median months from PCa diagnosis (range)
71 (3-356)

Prior prostate cancer therapies
Radical prostatectomy only	49.5%
Radiation therapy only	14.9%
Radical prostatectomy and radiation therapy	35.6%
At least 1 prior systemic therapy	27.9%
Gleason score
<8	73.6%
≥8	26.4%

PSA (ng/mL): Median (range) 0.8 (0.17-98.45)
<0.5	34.2%
0.5-<1.0	18.3%
1.0-<2.0	16.3%
2.0-<5.0	16.3%
≥5.0	14.9%

ADT=androgen deprivation therapy; BCR=biochemical recurrence; CLR=correct localization rate; CT=computed tomography; FDA=US Food and Drug Administration; MRI=magnetic resonance imaging; PET=positron emission tomography; PPV=positive predictive value; PSA=prostate-specific antigen; RP=radical protastectomy.

Clinical Trial Design:

OSPREY COHORT B²

OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 patients 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 patients with radiologic evidence of recurrence

Patient Population

117 patients with radiologic evidence of recurrence

Baseline Conventional Imaging

CT, MRI, or bone scan 4-6 weeks before PYLARIFY® PET/CT

PSMA-targeted PET scan with PYLARIFY

A single dose of PYLARIFY 9 mCi (333 MBq) IV, followed by PET/CT after 1-2 hours

Evaluation

Lesions (biopsy) detected by conventional imaging, evaluated for presence or absence of PCa, other neoplasm, or deemed unevaluable

Secondary endpoints:

Specificity
Sensitivity

^*With subanalyses by region and PSA level

CT=computed tomography; MRI=magnetic resonance imaging; PCa=prostate cancer; PET=positron emission tomography; PPV=positive predictive value.

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

PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
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.
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.

PYLARIFY is well tolerated

Across multiple studies, PYLARIFY was well-tolerated, with no individual adverse reaction occurring in more than 2% of patients1

Adverse reactions that occurred in >0.5% of patients who received PYLARIFY® (N=593)*

In COHORT A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores†

Reference standards of truth in CONDOR

CONDOR included patients with a broad range of PSA levels and Gleason scores†

INDICATION

Hypersensitivity Reactions

Radiation Risks

INDICATION

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Across multiple studies, PYLARIFY was well-tolerated, with no individual adverse reaction occurring in more than 2% of patients¹

Adverse reactions that occurred in >0.5% of patients who received PYLARIFY® (N=593)^*

In COHORT A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores^†

CONDOR included patients with a broad range of PSA levels and Gleason scores^†