Piflufolastat (18F) Wins Approval in Switzerland for Detecting PSMA+ Lesions in Prostate Cancer

Piflufolastat (18F) in Prostate Cancer | Image Credit:

© Sebastian Kaulitzki – stock.adobe.com

Switzerland has granted marketing authorization to piflufolastat (18F) [Pylclari; formerly (18F)-DCFPyL] for the detection of prostate-specific membrane antigen (PSMA)–positive lesions with PET in select adult patients with prostate cancer.1

Specifically, the imaging agent is indicated for primary staging in patients with high-risk prostate cancer prior to initial curative therapy; and to localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary curative-intent treatment.

“We are pleased with the growing availability of [piflufolastat (18F)] to reach more nuclear medicine physicians and their patients across Europe,” Benoit Woessmer, PET Europe chief executive officer of Curium, stated in a news release. “We are extremely proud to be improving the choice of diagnostic radiopharmaceuticals available to our customers in Switzerland—ultimately for the benefit of patients with prostate cancer.”

In May 2021, the FDA approved piflufolastat (18F) [Pylarify] to identify suspected metastasis or recurrence of prostate cancer.2 The imaging agent was also approved in the European Union (EU) in July 2023.1

The FDA approval was supported by data from the phase 2/3 OSPREY (NCT02981368) and phase 3 CONDOR (NCT03739684) trials, whereas the EU approval was based on findings from the phase 3 PYTHON trial (NCT04734184).3

In PYTHON, piflufolastat (18F) demonstrated a detection rate of first prostate cancer biochemical recurrence of 58% in patients with rising PSA levels (n = 201) compared with 40% for (18F) fluoromethylcholine (n = 201; P < .0001), meeting the primary end point of the study.4

Notably, the detection rate benefit was improved with piflufolastat (18F) across various levels of rising PSA. In patients with a PSA level of no more than 0.5 ng/mL, the detection rates were 35% (n = 26/74) for piflufolastat (18F) vs 30% (n = 22/74) for (18F) fluoromethylcholine. For those with a PSA level of 0.5 to no more than 1.0 ng/mL, the respective detection rates were 55% (n = 17/31) vs 32% (n = 10/31). For patients with PSA levels ranging from 1.01 to less than 2.0 ng/mL, the detection rates were 68% (n = 13/19) for piflufolastat (18F) compared with 32% (n = 6/19) for (18F) fluoromethylcholine. In those with a PSA level higher than 2.0 ng/mL, the respective detection rates were 88% (n = 50/57) vs 68% (n = 39/57), respectively.

Imaging results led to a change in disease management for 44% of patients (n = 90/204) who received piflufolastat (18F) vs 29% (n = 58/202) of patients given (18F) fluoromethylcholine.

The prospective, open-label PYTHON study enrolled patients at least 18 years of age with histopathologically confirmed prostate adenocarcinoma who had suspected first recurrence of prostate cancer per rising PSA levels after initial curative-intent therapy with a PSA level of at least 0.2 ng/mL confirmed by a subsequent PSA determination; or after radiation therapy with a PSA level at least 2 ng/mL above the nadir after therapy, irrespective of the serum concentration of the nadir.4,5

Investigators excluded patients with an ECOG performance status of more than 2, those with a history of prior salvage therapies, patients with a history of adjuvant radiotherapy, and those with a history of cryotherapy.5 Ongoing androgen deprivation therapy (ADT) or receipt of ADT within 30 days also prevented patients from enrolling.

Patients underwent imaging with piflufolastat (18F) or (18F) fluoromethylcholine within 12 days of enrollment.4

The study’s primary end point was the detection rate for each imaging agent, defined as the percentage of positive PET/CT scans identified by 3 central imaging readers.

“b.e. Imaging has proven to be a crucial supplier for the whole range of Curium’s SPECT radiopharmaceuticals for Switzerland,” Michel Wuillemin, PhD, MS, managing director at b.e. Imaging, added in the news release.1 “The extension of the partnership with Curium to PSMA PET imaging with [piflufolastat (18F)] underscores b.e. Imaging’s focus in the field of prostate cancer. Curium’s [piflufolastat (18F)] is in line with b.e. Imaging’s experience in the field of radioligand therapy for patients with prostate cancer.”

References

1. Curium receives marketing authorization in Switzerland for Pylclari – an innovative 18F-PSMA PET tracer indicated in patients with prostate cancer. News release. Curium. May 12, 2025. Accessed May 13, 2025. https://www.curiumpharma.com/2025/05/12/marketing-authorization-switzerland-pylclari/
2. 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. May 27, 2021. Accessed May 13, 2025. https://www.businesswire.com/news/home/20210527005291/en/Lantheus-Receives-U.S.-FDA-Approval-of-PYLARIFY-piflufolastat-F-18-Injection-the-First-and-Only-Commercially-Available-PSMA-PET-Imaging-Agent-for-Prostate-Cancer
3. Curium announces publication of [18F]DCFPyL versus [18F]fuoromethylcholine results from European phase III study (PYTHON trial). News release. Curium. July 21, 2023. Accessed May 13, 2025. https://www.curiumpharma.com/de/2023/07/21/python-trial-phase3-study/
4. Oprea-Lager DE, Gontier E, García-Cañamaque L, et al. [18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in biochemical recurrence of prostate cancer (PYTHON): a prospective, open label, cross-over, comparative study. Eur J Nucl Med Mol Imaging. 2023;50(11):3439-3451. doi:10.1007/s00259-023-06301-5
5. A prospective study on 18F-DCFPyL PET/​CT imaging in biochemical recurrence of prostate cancer (Python). ClinicalTrials.gov. Updated February 2, 2021. Accessed May 13, 2025. https://clinicaltrials.gov/study/NCT04734184