Curium, a world leader in nuclear medicine, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) for primary staging of patients with high-risk PCa prior to initial curative therapy and 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.
Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, “This positive CHMP opinion for PYLCLARI® is an important step forward in our goal of redefining the experience of cancer through our trusted legacy in nuclear medicine. We are extremely pleased with the CHMP positive opinion and recommendation to grant a marketing authorization in Europe for PYLCLARI®, a diagnostic imaging medicine for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer, based on the Phase III PYTHON clinical trial conducted in Europe and the Phase III OSPREY and CONDOR clinical trials conducted in the U.S.”
Benoit Woessmer, PET Europe CEO at Curium added, “This CHMP positive opinion is a very important milestone for Curium, our customers, and their patients. Upon its approval, PYLCLARI® will become available across Europe to help patients along their prostate cancer journey. We are very excited to bring PYLCLARI® to the market and contribute to improving the set of diagnostic tools available to better diagnose and monitor prostate cancer. PSMA PET with PYLARIFY® is the standard of care in the U.S. We are looking forward to answering the high expectations of the nuclear medicine community when it comes to having the right tool reliably available to address this fast-growing pathology.”
Curium submitted its Marketing Authorization Application for Piflufolastat (18F) to the EMA in July 2022. The CHMP’s positive opinion on PYLCLARI® will be referred to the European Commission, which will deliver a final decision in approximately two months.
In the U.S., [18F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY® (Piflufolastat F 18 Injection) and sold by Lantheus. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed.
