17th June 2024

Curium Continues to Make Strong Progress in European roll-out of Pylclari® – ¹⁸F-PSMA PET Diagnostics of Patients With Prostate Cancer

  • First doses of PYLCLARI® administered in Austria in early May 2024
  • PYLCLARI® now available in France, Germany, Greece, Italy, and the Netherlands

(Paris, France – 17 June 2024) – Curium, a world leader in nuclear medicine, today announced that with first doses in Austria administered in May 2024, it is making strong progress in the European roll-out of PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in 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

Benoit Woessmer, PET Europe CEO at Curium commented, “Today’s news that PYLCLARI® is now available to patients with prostate cancer in Austria is a testament to Curium’s dedication to and ambition for the country and health care professionals in Austria. PYLCLARI® is currently available in six European countries – with more countries planned for first doses in 2024. We are extremely proud to be improving the choice of diagnostic radiopharmaceuticals available to physicians to better diagnose prostate cancer.”

In Austria, prostate cancer is one of the most common cancers among men with around 7,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced in Austria by Curium at its Linz premises, with first doses administered at KABEG Klinikum Klagenfurt and a hospital in Linz. Authorization to produce PYLCLARI® at Curium’s Linz site was granted by Austria’s Österreichische Agentur für Gesundheit und Ernährungssicherheit in October 2023.

For more information about PYLCLARI®:  www.pylclari.com

In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 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 by Curium from Progenics, a Lantheus company, in 2018.