On July 28, 2023 Curium, a world leader in nuclear medicine, reported 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 (Press release, Curium, JUL 28, 2023, View Source [SID1234633479]):
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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.