PYLCLARI ((18F) piflufolastat) - Prostate cancer (PCa)

The Committee deems that the clinical benefit of PYLCLARI ((¹⁸F) piflufolastat) 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 settings:

• Primary staging of patients with high-risk PCa prior to initial curative therapy,
• To localise recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with
  curative intent.”

Considering:

• the diagnostic performance data with (¹⁸F) piflufolastat PET in cohort B of the OSPREY study and in the CONDOR study, demonstration of the superiority versus (¹⁸F) fluorocholine in the PYTHON study and the absence of findings relative to the impact on patient management based on clinically relevant criteria,
• 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 PYLCLARI ((¹⁸F) piflufolastat) solution for injection provides no clinical added value (CAV V) in the diagnostic strategy for prostate cancer, in the following clinical situations:

• Primary staging of patients with high-risk PCa prior to initial curative therapy,
• To localise recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with.