Regulatory Decision Summary for Illuccix
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of the submission is to seek marketing authorization for Illuccix (kit for the preparation of gallium (68Ga) PSMA-11 injection). After evaluation of the submitted data package, Health Canada authorized Illuccix for the following indication: Illuccix (kit for the preparation of gallium (68Ga) PSMA-11 injection), after radiolabeling with gallium (68Ga), is indicated for use with positron emission tomography (PET) of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
1) with suspected metastasis who are suitable for initial definitive therapy; and
2) with suspected recurrence with elevated serum prostate specific antigen (PSA) level.
Why was the decision issued?
Authorization of Illuccix was primarily based on publicly available data in the scientific literature in accordance with the Health Canada guidance document Drug Submissions Relying on Third-Party Data (Literature and Market Experience). Two pivotal well-controlled phase 3 studies were provided to support the use of Illuccix for detection and localization of prostate specific membrane antigen (PSMA) positive prostate cancer: In the first trial, a total of 277 subjects received a single mean dose of 196 ± 35 MBq (5.3 ± 0.9 mCi) of 68Ga-PSMA-11 via intravenous injection. The primary efficacy endpoints were sensitivity, specificity, positive and negative predictive value (PPV, NPV) of PSMA PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis. The sensitivity, specificity, positive predictive value, and negative predictive value of 68Ga-PSMA-11 PET based on the majority reads were 40%, 95%, 75%, and 81% per-patient level. In second study, a total of 316 subjects were included in the efficacy cohorts. The patient level positive predictive value was 84%.
For more information on Health Canada's decision, please view the Summary Basis of Decision.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ILLUCCIX | 02531836 | TELIX PHARMACEUTICALS (US), INC. | GALLIUM (68Ga) GOZETOTIDE 25 MCG / VIAL |