Curium has announced the commercial availability of piflufolastat (18F) (Pylclari; (18F)-DCFPyL) in Spain for the detection of prostate-specific membrane antigen (PSMA)-positive lesions using PET imaging in patients diagnosed with prostate cancer. This marks a significant expansion of the tracer's availability across Europe.
The availability of PYLCLARI in Spain is an important milestone for patients with prostate cancer and underscores our dedication to improving the choice of diagnostic PET radiopharmaceuticals,” said Benoit Woessmer, PET Europe CEO at Curium.
European Expansion
Following the European Commission's marketing authorization in July 2023, piflufolastat (18F) has been progressively launched in several European countries. The first commercial doses were offered in Greece in November 2023, followed by Italy in February 2024, the Netherlands in March 2024, Germany and France in May 2024, Austria in June 2024, and now Spain.
Clinical Efficacy and Safety
Piflufolastat (18F) received FDA approval in the United States in May 2021, based on data from the phase 3 OSPREY (NCT02981368) and CONDOR (NCT03739684) trials. These trials evaluated the safety and efficacy of the tracer in various clinical settings.
The OSPREY trial included 385 patients divided into two cohorts: cohort A (252 evaluable patients with high-risk prostate cancer undergoing radical prostatectomy with lymphadenectomy) and cohort B (93 evaluable patients with suspected recurrent/metastatic prostate cancer on conventional imaging).
Data from the OSPREY trial demonstrated high specificity and positive predictive value (PPV) with piflufolastat (18F) prior to initial therapy. In cohort A, the median specificity was 97.9% among three readers, with a median sensitivity of 40.3%. The median PPV and negative predictive value were 86.7% and 83.2%, respectively. In cohort B, the median sensitivity was 95.8%, and the PPV for extraprostatic lesions was 81.9%.
The CONDOR trial involved 208 men with prostate cancer and uninformative baseline imaging, with a median baseline PSA of 0.8 ng/mL. The primary endpoint was the correct localization rate (CLR), defined as PPV with anatomic lesion colocalization between piflufolastat (18F) and a composite standard of truth.
The CONDOR trial showed high rates of CLR and detection with piflufolastat (18F) in patients with biochemical recurrent prostate cancer, even in those with low PSA values. The CLR ranged from 84.8% to 87.0%. The disease detection rate, defined as one lesion detected per patient, was 59% to 66%. Overall, 63.9% of patients experienced a change in intended management following piflufolastat (18F) imaging.
Adverse events observed in both trials occurred in 2% or less of patients and included headache, dysgeusia, and fatigue. One patient with a history of allergic reactions reported a delayed hypersensitivity reaction.
