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19th March 2024

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

(Paris, France – 19th March 2024) – Curium, a world leader in nuclear medicine, announced that today in the Netherlands the first commercial dose of PYLCLARI® has been sold. PYLCLARI® (INN: Piflufolastat (18F) also known as (18 F)-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 that with today’s news of first commercial supply in the Netherlands, PYLCLARI® is now available to more nuclear medicine physicians and their patients in three European countries – Greece, Italy, and in the Netherlands where the production will be done by our partner BV Cyclotron VU in Amsterdam. With our focus on redefining the experience of cancer through our trusted legacy in nuclear medicine, Curium is proud to be improving the choice of diagnostic modalities available to our customers across Europe – ultimately for the benefit of patients with prostate cancer.”

Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI® in the European Union, followed by first commercial doses in Greece in November 2023, and in Italy in February 2024.

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.