On May 12, 2025 Curium reported that it has marketing authorization in Switzerland for the distribution of PYLCLARI (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) (Press release, Curium Pharma, MAY 12, 2025, View Source [SID1234652875]). PYLCLARI is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer in the following clinical settings:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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
Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI in the European Union. b.e. Imaging currently distributes Curium’s entire suite of SPECT radiopharmaceuticals across Switzerland and following an exclusive distribution rights agreement in September 2023, will now also distribute PYLCLARI.
Dr. Michel Wuillemin, Managing Director at b.e. Imaging commented, "b.e. Imaging has proven to be a crucial supplier for the whole range of Curium’s SPECT radiopharmaceuticals for Switzerland. The extension of the partnership with Curium to PSMA PET imaging with PYLCLARI underscores b.e. Imaging’s focus in the field of prostate cancer. Curium’s PYLCLARI is in line with b.e. Imaging’s experience in the field of radioligand therapy for patients with prostate cancer."
Benoit Woessmer, PET Europe CEO at Curium commented, "We are pleased with the growing availability of PYLCLARI to reach more nuclear medicine physicians and their patients across Europe. With today’s announcement, 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 Switzerland, prostate cancer is the most common cancer among men with around 7,800 new cases diagnosed nationwide every year. Today’s announcement is part of the continued roll-out of PYLCLARI across the European Union, which with the addition of Switzerland, is now available for patients with prostate cancer in 12 countries. In the U.S., Lantheus received approval for PYLARIFY (Piflufolastat (18F) Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed to Curium from Progenics, a Lantheus company, in 2018.