Regulatory Decision Summary for Illuccix

The purpose of the submission was to seek an indication expansion for Illuccix (kit for the preparation of gallium [⁶⁸Ga] gozetotide injection); to include the identification of patients with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom prostate-specific membrane antigen (PSMA)-targeted therapy is indicated.

Authorization of the indication expansion of Illuccix was primarily based on data from a clinical study (VISION) which compared the efficacy of a PSMA-targeted therapy (lutetium [¹⁷⁷Lu] vipivotide tetraxetan) plus best standard of care with best standard of care in metastatic castration-resistant prostate cancer patients (mCRPC). Only patients with PSMA-positive lesions were eligible for randomization and receipt of PSMA-targeted therapy, and gallium (⁶⁸Ga) gozetotide positron emission tomography (PET) was used as an imaging agent to determine eligibility. Of the 1,003 adult male patients with progressive mCRPC enrolled in the study, 86.6% were found to be PSMA-positive and 12.6% were found to be PSMA-negative. Improved overall survival was reported in the PSMA-targeted therapy arm. No serious adverse reactions were identified in the study. The most common grade 1 adverse event associated with the use of gallium (⁶⁸Ga) gozetotide PET as an imaging agent was fatigue (1.2%).

Based on the evidence reviewed, the benefit/risk profile is considered acceptable for Illuccix under the recommended condition of use.

The recommended Illuccix radioactivity dose in adults is 111 to 259 MBq (3 to 7 mCi) as a slow intravenous bolus injection.

Overall, the benefit-harm-uncertainty profile was favourable for Illuccix for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Illuccix, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.