The approval comes after a recommendation for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use in May 2023.
The European Commission has granted marketing authorization to piflufolastat (18F) (Pylclari) for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adult patients with prostate cancer (PCa), Curium, the developer of the technology, announced in a news release.1
“The decision by the European Commission means that Pylclari will soon be available across Europe for the benefit of prostate cancer patients. With the leading PET radiopharmaceutical network in Europe, we are pleased to be improving the set of diagnostic tools available to better diagnose and monitor prostate cancer – ultimately for the benefit of prostate cancer patients,” said Benoit Woessmer, CEO of Curium, in the news release.1
The approval comes after a recommendation for marketing authorization in May 2023 from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
According to the news release,1 the PSMA-PET tracer is indicated for the following clinical settings:
Curium currently has 32 production sites that can supply the imaging agent in 18 countries. When in full production, piflufolastat (18F) will be the most widely available 18F-PSMA tracer in Europe, according to the company
Piflufolastat (18F) was approved in the United States as piflufolastat F 18 (Pylarify) in May 2021.2 The FDA approval was based on data from the phase 3 OSPREY (NCT02981368) and CONDOR (NCT03739684) trials.
In both studies, patients with prostate cancer were given a single dose of piflufolastat F 18.
The OSPREY3 trial enrolled 385 patients who were divided into 2 cohorts: Cohort A of men with high-risk prostate cancer undergoing radical prostatectomy with lymphadenectomy and Cohort B of men with suspected recurrent/metastatic prostate cancer on conventional imaging. The primary end points were specificity and sensitivity.
Data showed greater specificity and positive predictive values (PPVs) with piflufolastat F 18 compared with conventional imaging prior to initial therapy. Overall, median specificity with piflufolastat F 18 was 97.9% among 3 readers. Median PPV was 86.7% with piflufolastat F 18, compared with 81.9% with conventional imaging.
The CONDOR4 study enrolled 208 men with a median baseline PSA of .8 ng/mL. The primary end point was correct localization rate, defined as PPV with anatomic lesion colocalization between piflufolastat F 18 and a composite standard of truth.
Findings showed high rates of correct localization and detection with piflufolastat F 18 in patients with biochemical recurrent prostate cancer, including in those with low PSA values. Overall, the correct localization rate was found to be 84.8% to 87.0%. The disease detection rate was 59% to 66%.
Adverse events from both trials were observed among less than 2% of patients. These included headache, dysgeusia, and fatigue. One patient with a history of allergic reactions also reported experiencing a delayed hypersensitivity reaction to the treatment.
1. Curium receives marketing authorization in the EU for Pylclari, an innovative 18F-PSMA PET tracer indicated in adults with prostate cancer. News release. Curium. July 28, 2023. Accessed July 31, 2023. https://www.curiumpharma.com/2023/07/28/pylclari-receives-ec-ma/
2. Lantheus received US FDA approval of PYLARIFY (piflufolastat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. News release. Lantheus Holdings, Inc. May 27, 2021. Accessed July 31, 2023. https://investor.lantheus.com/news-releases/news-release-details/lantheus-receives-us-fda-approval-pylarifyr-piflufolastat-f-18
3. Pienta KJ, Gorin MA, Rowe SP, et al. A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPyL in prostate cancer patients (OSPREY). J Urol. Published online February 26, 2023. Accessed July 31, 2023. doi:10.1097/JU.0000000000001698
4. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: Results from the CONDOR phase III, multicenter study. Clin Cancer Res. Published online February 23, 2023. Accessed July 31, 2023. doi:10.1158/1078-0432.CCR-20-4573