Curium Advances European Roll-Out of PYLCLARI® for Prostate Cancer Diagnostics

Curium, a global leader in nuclear medicine, has recently marked a significant milestone with the administration of the first doses of PYLCLARI® in Austria in early May 2024. This advancement is part of Curium's broader European strategy to roll out PYLCLARI® (INN: Piflufolastat (18F), also known as (18F)-DCFPyL), which is now also available in France, Germany, Greece, Italy, and the Netherlands.

PYLCLARI® is a specialized diagnostic radiopharmaceutical used with positron emission tomography (PET) to detect prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer patients. It is particularly used in the primary staging of patients with high-risk prostate cancer before initial curative therapy, and in localizing recurrent prostate cancer in patients with rising serum prostate-specific antigen (PSA) levels following primary curative treatment.

Benoit Woessmer, CEO of PET Europe at Curium, expressed pride in the launch of PYLCLARI® in Austria. He emphasized Curium's commitment to enhancing the diagnostic options available to physicians, thereby improving prostate cancer diagnosis and treatment outcomes. This expansion into Austria, where prostate cancer is a prevalent condition with approximately 7,000 new cases each year, underscores Curium's dedication to addressing significant health challenges through innovative medical solutions.

The initial doses of PYLCLARI® in Austria were produced at Curium's Linz facility. This production site was authorized by Austria's Österreichische Agentur für Gesundheit und Ernährungssicherheit in October 2023. The first doses were administered at KABEG Klinikum Klagenfurt and a hospital in Linz, marking the start of what Curium hopes to be a broader implementation across Europe throughout 2024.

In the United States, PYLARIFY® (Piflufolastat F 18 Injection), which is the counterpart to PYLCLARI®, received approval from the Food and Drug Administration (FDA) in May 2021. It has since become the most widely used PSMA PET agent in the U.S. market. Curium obtained the European rights to this agent from Progenics, a subsidiary of Lantheus, in 2018.

Curium is renowned for its leadership in nuclear medicine, with a focus on developing, manufacturing, and distributing top-tier radiopharmaceutical products globally. The company serves over 14 million patients annually through its extensive operations in Europe and the United States, providing solutions for SPECT, PET, and therapeutic radiopharmaceutical needs. Curium's name pays homage to the pioneering scientists Marie and Pierre Curie, who played pivotal roles in the discovery of radioactive elements, symbolizing the company's dedication to advancing nuclear medicine.

Curium continues to drive innovation and excellence in nuclear medicine, aiming to offer unparalleled service and medical solutions that improve patient outcomes around the world.