A New Breakthrough: Curium’s PYLCLARI™18F-PSMA Approved in EU for Prostate Cancer Diagnosis

The European Commission has granted Curium, a world leader in nuclear medicine, approval to market PYLCLARI™, formerly known as (18F)-DCFPyL. This PET-based drug is used to detect prostate-specific membrane antigen (PSMA) positive lesions in adults with prostate cancer. Physicians now have a powerful new tool to help diagnose and better treat this life-threatening condition.

Prior to beginning initial curative therapy, patients with high-risk prostate cancer must undergo a primary staging process. This process will enable clinicians to devise the most effective treatment plan for each individual patient, ensuring they can receive the highest quality of care.

Patients with primary treatment of curative intent for prostate cancer (PCa) may experience a relapse when their serum prostate-specific antigen (PSA) levels begin to rise. Localizing the recurrence is key to ensuring successful treatment of the recurrence and helping patients manage their cancer long-term.

The European Medicines Agency has given its highest endorsement to the marketing authorization approval of the medicine, following a positive recommendation from The Committee for Medicinal Products for Human Use in May 2023. This marks a major milestone in bringing this important medicine a step closer to those who need it.

The successful clinical development and subsequent EU marketing authorization of PYLCLARI™ furthers Curium’s mission to redefine the experience of cancer in nuclear medicine. Dr. Sakir Mutevelic, Curium’s Chief Medical Officer, expressed his enthusiasm in delivering PYLCLARI® to prostate cancer patients and working with health care professionals across the EU.

“We are very pleased to receive marketing authorization in the EU for PYLCLARI™,” said Mutevelic. “It is a great honor to be able to bring this innovative treatment to those fighting prostate cancer.”

The European Commission’s approval of PYLCLARI™ will soon mean that prostate cancer patients across Europe will benefit from improved diagnostic tools and better monitoring. According to Benoit Woessmer, CEO of Curium’s PET Europe, “With our leading PET radiopharmaceutical network in Europe, we are delighted to provide life-changing solutions to prostate cancer patients.”

Curium is proud to offer the widest European network of PET products production sites in Europe – with 32 production sites in 18 countries across the region. Boasting the widest distribution of this kind, PYLCLARI™ stands as the most available 18F-PSMA tracer when it is in full production.

Prostate cancer is one of the most common forms of cancer in men across Europe, with 23 percent of all cancer cases arising in 2020 and 10 percent of all cancer-related deaths occurring in men. This tragic diagnosis is increasingly affecting men and their families, so it’s essential to stay informed and take proactive steps to check for the disease.

In May 2021, the FDA granted approval of PYLARIFY® (Piflufolastat F 18 Injection) – a product of Lantheus in the United States – as the #1 PSMA PET Imaging Agent in the U.S. market. A European license for the imaging agent had already been granted to Curium by Progenics, the Lantheus company, back in 2018.

About Curium

Curium is revolutionizing the way medical care is delivered – through our nuclear medicine products that are leading the world in the latest innovations. We manufacture, distribute, and develop world-class radiopharmaceutical products that are helping countless patients, across the globe, every day.

Our legacy of excellence combined with our pioneering spirit helps us continue to drive forward fresh ideas to deliver the best quality experience and superior service for health professionals and their patients.

At Curium, we strive to honor the legacy of Marie and Pierre Curie by delivering life-saving nuclear medicine solutions to more than 14 million patients worldwide. With our state-of-the-art production facilities located in the United States and Europe, we provide SPECT, PET, and therapeutic radiopharmaceuticals to help fight life-threatening diseases. Curium – a nod to the radioactive element named after the Curies – marks the beginning of a revolution in nuclear medicine.

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