RADELUMIN ([18F] PSMA-1007) - Prostate cancer

The Committee deems that the clinical benefit of RADELUMIN ([18F] PSMA-1007) solution for injection is substantial in the MA indication: “[…] for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in [the following clinical setting]: Primary staging of patients with high-risk PCa prior to primary curative therapy, […]”.

Considering:

• the diagnostic performance data with [18F] PSMA-1007 PET in five studies (from a review of the literature) retained for analysis and the absence of robust data relative to the impact on patient management,
• the absence of evidence of an impact on mortality, morbidity or quality of life,
• its satisfactory safety profile,
• the medical need which remains partially met,

The Committee deems that RADELUMIN ([18F] PSMA-1007) solution for injection provides no clinical added value (CAV V) in the diagnostic strategy for prostate cancer, in the following clinical situation: primary staging of patients with high-risk PCa prior to primary curative therapy.