Curium Receives Marketing Authorization in the EU for PYLCLARI™, an Innovative 18F-PSMA PET Tracer Indicated in Adults With Prostate Cancer

PARIS, July 28, 2023 (GLOBE NEWSWIRE) — Curium, a world leader in nuclear medicine, announced that the European Commission has granted marketing authorization for PYLCLARI™ (INN: Piflufolastat (¹⁸F) formerly known as (¹⁸F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:

• Primary staging of patients with high-risk PCa prior to initial curative therapy
• To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent

Today’s decision follows the positive recommendation for marketing authorization approval by The Committee for Medicinal Products for Human Use of the European Medicines Agency in May 2023.

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium, commented, “We are very pleased to receive marketing authorization in the EU for PYLCLARI™. The successful clinical development and granted marketing authorization of PYLCLARI™ in the EU confirms our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine. We are looking forward to bringing PYLCLARI® to prostate cancer patients as well as to working together with health care professionals across the EU.”

Benoit Woessmer, PET Europe CEO at Curium, added, “The decision by the European Commission means that PYLCLARI™ will soon be available across Europe for the benefit of prostate cancer patients. With the leading PET radiopharmaceutical network in Europe, we are pleased to be improving the set of diagnostic tools available to better diagnose and monitor prostate cancer – ultimately for the benefit of prostate cancer patients.”

Curium currently has the widest European network of PET products production sites – 32 sites with the capability to supply in 18 countries. When in full production, PYLCLARI™ will be the most widely available ¹⁸F-PSMA tracer in Europe.

Prostate cancer is one of the most frequently diagnosed cancers in men in Europe, accounting for around 23 percent of all new cancer cases in 2020 and nearly 10 percent of all deaths due to cancer in men.

In the U.S., Lantheus received approval for [¹⁸F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 PSMA PET Imaging Agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.

For more information about PYLCLARI™: https://pylclari.eu

About Curium

Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named, and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com

For more information:
Ross Bethell
VP, Head of Global Communications
communications@curiumpharma.com