EU Approves Piflufolastat (18F) PSMA PET Imaging Agent for Prostate Cancer

The European Commission (EC) has approved piflufolastat (¹⁸F) (Pylclari; formerly [¹⁸F]-DCFPyL) for the detection of prostate-specific membrane antigen (PSMA)–positive lesions with positron emission tomography (PET) in adults with prostate cancer.¹

The imaging agent is indicated for the following clinical settings:

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

“We are very pleased to receive marketing authorization in the European Union [EU] for [piflufolastat (¹⁸F)]. The successful clinical development and granted marketing authorization of [piflufolastat (¹⁸F)] in the EU confirms our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine,” Sakir Mutevelic, MD, MSc, chief medical officer at Curium, stated in a news release. “We are looking forward to bringing [piflufolastat (¹⁸F)] to [patients with] prostate cancer as well as to working together with health-care professionals across the EU.”

The EC’s decision followed a recommendation for the approval of piflufolastat (¹⁸F) from the European Medicines Agency’s Committee for Medicinal Products for Human Use in May 2023.²

In May 2021, the FDA approved piflufolastat F 18 (Pylarify) injection to identify suspected metastasis or recurrence in patients with prostate cancer.³

The FDA approval was supported by findings from the phase 2/3 OSPREY (NCT02981368) and phase 3 CONDOR (NCT03739684) trials, which evaluated the safety and diagnostic performance of the imaging agent.

In cohort A (n = 252) of OSPREY, findings showed that piflufolastat F 18 led to an improvement in specificity and positive predictive value (PPV) compared with conventional imaging in patients at risk for metastatic prostate cancer prior to initial therapy. The median specificity for piflufolastat F 18 was 97.9% (95% CI, 94.5%-99.4%), and the median sensitivity was 40.3% (95% CI, 28.1%-52.5%) among 3 readers for pelvic nodal involvement. The median PPV and negative predictive value were 86.7% (95% CI, 69.7%-95.3%) and 83.2% (95% CI, 78.2%-88.1%), respectively.⁴

In CONDOR, in patients with biochemical recurrent prostate cancer, imaging with piflufolastat F 18 produced high correct localization and detection rates, including in patients with low PSA values, defined as a median PSA 0.8 ng/mL. In men (n = 208) with a median baseline PSA of 0.8 ng/mL (range, 0.2-98.4), the correct localization rate was 84.8% to 87.0% (95% CI, 77.8%-80.4%). Additionally, 63.9% of evaluable patients experienced a change in intended management after imaging with piflufolastat F 18. The disease detection rate was 59% to 66%.⁵

Data from the trials showed that the imaging agent was well tolerated. Across the OSPREY and CONDOR trials, 593 patients with various states of prostate cancer received a single dose of the agent. Headache, dysgeusia, and fatigue occurred in 2% or fewer of patients, and 1 patient (0.2%) who had a history of allergic reaction experienced a delayed hypersensitivity reaction.³

References

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 28, 2023. https://www.curiumpharma.com/2023/07/28/pylclari-receives-ec-ma/
2. Curium receives positive CHMP opinion of Pylclari for primary staging of patients with high-risk PCa prior to initial curative therapy and to localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent. News release. Curium. May 26, 2023. Accessed July 28, 2023. https://www.curiumpharma.com/2023/05/26/curium-receives-positive-chmp-opinion/
3. Lantheus receives US FDA approval of PYLARIFY (piflufolistat 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 28, 2023. https://bwnews.pr/2SynyAS
4. 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. 2021;206(1):52-61. doi:10.1097/JU.0000000000001698
5. 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. 2021;27(13):3674-3682. doi:10.1158/1078-0432.CCR-20-4573