Piflufolastat F-18

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

Retrieved on: 
Friday, July 28, 2023

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium, commented, “We are very pleased to receive marketing authorization in the EU for PYLCLARI™.

Key Points: 
  • 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.
  • When in full production, PYLCLARI™ will be the most widely available 18F-PSMA tracer in Europe.
  • 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.

RefleXion Highlights Clinical Study Results for Future Prostate Cancer Treatment

Retrieved on: 
Monday, June 26, 2023

The study results serve as the foundation for evaluating the use of RefleXion’s SCINTIX™ biology-guided radiotherapy with a prostate-specific PET radiotracer for controlling external-beam radiotherapy delivery to prostate cancer tumor targets.

Key Points: 
  • The study results serve as the foundation for evaluating the use of RefleXion’s SCINTIX™ biology-guided radiotherapy with a prostate-specific PET radiotracer for controlling external-beam radiotherapy delivery to prostate cancer tumor targets.
  • View the full release here: https://www.businesswire.com/news/home/20230626297838/en/
    The prostate-specific PET radiotracer, 18F-DCFPyL, signals avid bone metastasis in a patient with prostate cancer.
  • The prostate-specific PET radiotracer used in the presented study – 18F-DCFPyL (PyL) – binds to prostate-specific membrane antigen (PSMA), a protein that is expressed in significantly elevated amounts by prostate cancer cells.
  • Also recently approved by the FDA for diagnosing and staging prostate cancer, PyL can accurately and precisely pinpoint tumors in both the prostate and in other body areas where the cancer may have spread or metastasized.

Curium Receives Positive CHMP Opinion of PYLCLARI® 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 A

Retrieved on: 
Friday, May 26, 2023

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.

Key Points: 
  • 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.
  • 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.
  • The CHMP’s positive opinion on PYLCLARI® will be referred to the European Commission, which will deliver a final decision in approximately two months.

Lantheus Presents Data Reinforcing Real-World Clinical Utility of Piflufolastat F 18 PET Scanning in Men with Recurrent Prostate Cancer and Low PSA Levels

Retrieved on: 
Thursday, February 16, 2023

Piflufolastat F 18 is a PSMA-targeted radiopharmaceutical approved in the US for imaging prostate cancer patients both at the time of initial staging and at disease recurrence.

Key Points: 
  • Piflufolastat F 18 is a PSMA-targeted radiopharmaceutical approved in the US for imaging prostate cancer patients both at the time of initial staging and at disease recurrence.
  • In this study, researchers sought to evaluate the clinical utility of piflufolastat F 18 scanning in men with very low/low PSA levels (
  • “PYLARIFY has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” said Dr. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval.
  • The abstract, “Changes in planned disease management after piflufolastat F 18 PET/CT in men with biochemically recurrent prostate cancer and low PSA levels: a secondary analysis from the CONDOR study,” is available on meetinglibrary.asco.org .