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Important Safety Information Full Prescribing Information

Illuccix® has established clinical efficacy across prostate cancer stages demonstrated in pivotal trials with 68Ga-PSMA-111,a

INITIAL STAGING

Efficacy of diagnostic performance confirmed through histopathology comparison1

BIOCHEMICAL RECURRENCE

High rate of detection confirmed even at PSA levels lower than 2 ng/mL1

VARIOUS REGIONS

Demonstrated detection including bone, prostate bed, pelvic lymph node, and extrapelvic soft tissue1

Initial Staging
BCR

National Comprehensive Cancer Network (NCCN) Guidelines and Society of Nuclear Medicine and Molecular Imaging (SNMMI) appropriate use criteria recommendations include 68Ga-PSMA-11 PET/CT or PET/MRI across different stages of prostate cancer2,3,b

View All Recommendations

a68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.

bThese guidelines do not recommend use of a particular radiopharmaceutical.

Initial Staging: PSMA-PreRP Trial

Efficacy established at initial staging1

Illuccix® accuracy demonstrated in a pivotal trial with 68Ga-PSMA-11 by histopathology comparison

The open-label, prostate-specific membrane antigen-preprostatectomy (PSMA-PreRP) study (N=325) compared majority positron emission tomography (PET) reads to pelvis lymph node histopathology results.1

In an exploratory subgroup analysis based on summed Gleason score, there was a numerical trend toward more true positives in patients with a Gleason score of ≥8 compared to those with a Gleason score of ≤7.1

In an exploratory analysis of pelvic nodal metastasis in all patients, including those without histopathology reference standard, and using an imputation method1,c:

  • Imputed sensitivity was 47% (95% CI: 38%-55%)
  • Imputed specificity was 74% (95% CI: 68%-80%)
View Trial Design

Patient-Level Performance of 68Ga-PSMA-11 for Detection of Pelvic Lymph Node Metastasis (n=123)1,d

Among the pool of 6 readers, sensitivity ranged from 36% to 60%, specificity from 83% to 96%, positive predictive value from 38% to 80%, and negative predictive value from 80% to 88%.

NPV, negative predictive value; PPV, positive predictive value.

cThe imputation method was based on patient-specific factors.

dWith region matching where at least one true positive region defines a true positive patient.

e95% confidence interval (CI).

Biochemical Recurrence: PSMA-BCR-Trial

Efficacy established at biochemical recurrence even at low PSA levels1

Illuccix® provides a high rate of detection across regions as seen in a pivotal trial with 68Ga-PSMA-111

  • Patients with biochemical recurrence after radical prostatectomy were enrolled in this prospective study (N=635)
  • Of the 210 evaluable patients, 192 patients (91%) were found to be true positive in one or more regions against the composite reference standard (95% CI: 88%-95%)

PET results and percent PET positivity stratified by serum PSA level (n=628)1,f

Detection rates increased with increasing PSA levels.

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PSA
(ng/mL)

PET positive patients

Total

TP

FP

With reference standard

Without reference standard

PET negative patients

Percent PET positivityg (95% CI)

<0.5

48

11

1

12

36

87

36%
(27%-44%)

≥0.5 and <1

44

15

3

18

26

35

56%
(45%-67%)

≥1 and <2

71

29

1

30

41

15

83%
(75%-91%)

≥2

299

137

13

150

149

29

91%
(88%-94%)

Total

462

192

18

210

252

166

74%
(70%-77%)

TP, true positive; FP, false positive.

f7 patients were excluded from this table due to protocol deviations.

gPercent PET positivity = PET positive patients/total patients scanned.

CLR is defined as the true positive percentage among all positive PET scans1,h

In 2 exploratory analyses of gallium Ga 68 gozetotide PET positive patients without reference standard information using an imputation approach1,i

  • 72% (340/475) were imputed as true positive in one or more regions (95% CI: 68%-76%)
  • 54% (340/635) were correctly detected as true positive (95% CI: 50%-57%) among all BCR patients who received a PET scan, whether it was read as positive or negative

CLR, correct localization rate.

hTP/TP+FP.

fUsing an estimated likelihood that ≥1 location-matched PET positive lesion was reference standard positive based on patient-specific factors.

Illuccix® identified lesions across all vital regions as seen in a pivotal trial with 68Ga-PSMA-111,j

74% of patients (n=469) had ≥1 positive region detected by 68Ga-PSMA-11 PET majority read

jTotal does not add up to 100% due to rounding of percentages.

View Trial Design
Learn How to Read an Illuccix®  Scan

Guidelines

Recommendations of guidelines on PSMA PET/CT or PET/MRI

Guideline

When 68Ga-PSMA-11 is recommended for use

National Comprehensive Cancer Network (NCCN)2,k

To be considered for full body (soft tissue and bone) imaging and equivocal results on initial bone imaging at:

  • Initial staging of unfavorable intermediate,l high or very high-risk prostate cancer
  • Biochemical recurrence (BCR) after initial definitive therapy or progression of N1 disease on androgen deprivation therapy (ADT), or localized on observation
  • Progression of nonmetastatic and metastatic castration-naïve prostate cancer
  • Nonmetastatic castration-resistant prostate cancer (nmCRPC) with increasing PSA or radiographic evidence of metastases

Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (CT, MRI) at both initial staging and BCR, the panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as an equally effective, if not more effective front-line imaging tool for these patients.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

See full recommendation guidelines

Society of Nuclear Medicine and Molecular Imaging (SNMMI)3,k

SNMMI appropriate use criteria (AUC) describe clinical scenarios for 68Ga-PSMA-11 PET/CT or PET/MRI use at different prostate cancer stages including:

  • Newly diagnosedm unfavorable intermediate, high-risk, or very high-risk prostate cancer
  • Biochemical recurrence
  • nmCRPC on conventional imaging

See full recommendation guidelines

kThese guidelines do not recommend use of a particular radiopharmaceutical.

lWith at least one of the following: 2 or 3 intermediate risk factors, Grade Group 3, ≥ 50% biopsy cores positive (ie, ≥ 6 of 12 cores).

mPatients with suspected prostate cancer evaluated for biopsy and detection of intraprostatic tumor and patients with very low, low, and favorable intermediate-risk prostate cancer are described as “rarely appropriate”.

nScoring of this indication will likely be revisited and improved based on the outcomes of radioligy and therapy clinical trials.

Guideline and when 68Ga-PSMA-11 is recommended for use

National Comprehensive Cancer Network (NCCN)2,k

To be considered for full body (soft tissue and bone) imaging and equivocal results on initial bone imaging at:

  • Initial staging of unfavorable intermediate,l high or very high-risk prostate cancer
  • Biochemical recurrence (BCR) after initial definitive therapy or progression of N1 disease on androgen deprivation therapy (ADT), or localized on observation
  • Progression of nonmetastatic and metastatic castration-naïve prostate cancer
  • Nonmetastatic castration-resistant prostate cancer (nmCRPC) with increasing PSA or radiographic evidence of metastases

Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (CT, MRI) at both initial staging and BCR, the panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as an equally effective, if not more effective front-line imaging tool for these patients.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

See full recommendation guidelines

Society of Nuclear Medicine and Molecular Imaging (SNMMI)3,k

SNMMI appropriate use criteria (AUC) describe clinical scenarios for ⁶⁸Ga-PSMA-11 PET/CT or PET/MRI use at different prostate cancer stages including:

  • Newly diagnosedm unfavorable intermediate, high-risk, or very high-risk prostate cancer
  • Biochemical recurrence
  • nmCRPC on conventional imaging

See full recommendation guidelines

kThese guidelines do not recommend use of a particular radiopharmaceutical.

lWith at least one of the following: 2 or 3 intermediate risk factors, Grade Group 3, ≥ 50% biopsy cores positive (ie, ≥ 6 of 12 cores).

mPatients with suspected prostate cancer evaluated for biopsy and detection of intraprostatic tumor and patients with very low, low, and favorable intermediate-risk prostate cancer are described as “rarely appropriate”.

nScoring of this indication will likely be revisited and improved based on the outcomes of radioligy and therapy clinical trials.

NEXT: Safety

Indications and Usage

Illuccix®, after radiolabeling with Ga 68, 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

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide PET. 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 gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

Please see  full Prescribing Information.

Indications and Usage

Illuccix®, after radiolabeling with Ga 68, 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

References: 1. Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Prostate cancer (Version 1.2022). 3. Jadvar H, Calais J, Fanti S, et al. Appropriate use criteria for prostate-specific membrane antigen PET imaging. J Nucl Med. 2022;63(1):59-68.

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