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%) |
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
252 patients underwent surgery and had PLND evaluated locally by pathologists blinded to the imaging results. 16 patients did not undergo RP-PLND
- Specificity
- Sensitivity
- 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% |
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
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% |
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
Lesions (biopsy) detected by conventional imaging, evaluated for presence or absence of PCa, other neoplasm, or deemed unevaluable
- Specificity
- Sensitivity
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.
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.
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.
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.
