Piflufolastat (18F) enters commercial market in Spain - Urology Times
Piflufolastat (18F) (Pylclari) is now available in Spain for PSMA-positive lesion detection in prostate cancer patients, produced at Curium facilities in Madrid and Sevilla. It is indicated for high-risk prostate cancer staging and recurrence localization based on increasing serum PSA levels. The agent has been approved in the EU since July 2023 and in the US since May 2021, with high specificity, sensitivity, and positive predictive value demonstrated in phase 3 trials.
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Piflufolastat (18F) (Pylclari) is now available in Spain for PSMA-positive lesion detection in prostate cancer patients, produced at Curium facilities in Madrid and Sevilla. It is indicated for high-risk prostate cancer staging and recurrence localization based on increasing serum PSA levels. The agent has been approved in the EU since July 2023 and in the US since May 2021, with high specificity, sensitivity, and positive predictive value demonstrated in phase 3 trials.