Curium announces first commercial doses in Germany of PYLCLARI® – an innovative 18F-PSMA PET tracer indicated in patients with prostate cancer

(Paris, France – 6 May 2024) – Curium, a world leader in nuclear medicine, announced that today in Munich and Nurnberg, Germany the first commercial doses of PYLCLARI^® have been delivered. PYLCLARI^® (INN: Piflufolastat (¹⁸F) also known as (¹⁸F)-DCFPyL), is 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, “We are pleased with the growing availability of PYLCLARI^® to more nuclear medicine physicians and their patients across Europe. With today’s announcement, we are extremely proud to be improving the choice of diagnostic modalities available to our customers in Germany – ultimately for the benefit of patients with prostate cancer.”

In Germany, prostate cancer is the most common cancer among men with around 63,400 new cases diagnosed nationwide every year. Today’s announcement is part of the continued roll-out of PYLCLARI^® across the European Union, which is now available for patients with prostate cancer in Greece, Italy, and the Netherlands.

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

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 by Curium from Progenics, a Lantheus company, in 2018.