Pylclari is an 18F-PSMA positron emission tomography (PET) tracer that detects prostate-specific membrane antigen (PSMA) positive lesions with PET in adults with prostate cancer
Curium gets approval from EC to market Pylclari in the EU. (Credit: Curium)
Nuclear medicine company Curium announced that European Commission has granted marketing authorisation for Pylclari (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) in European Union (EU).
Pylclari is an innovative 18F-PSMA positron emission tomography (PET) tracer. It is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with PET in adults with prostate cancer (PCa).
It is designed for use in the primary staging of patients with high-risk PCa prior to initial curative therapy.
Additionally, Pylclari is intended to localise PCa recurrence in patients with a suspected recurrence based on growing serum prostate-specific antigen (PSA) levels post-primary treatment with curative intent.
The authorisation follows the positive recommendation for marketing authorisation approval by The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in May this year.
Pylclari will be available as a 1000 MBq/mL and 1500 MBq/mL solution for injection.
Curium chief medical officer Sakir Mutevelic said: “We are very pleased to receive marketing authorisation in the EU for Pylclari.
“The successful clinical development and granted marketing authorisation 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.”
Currently, Curium has a network of 32 PET product manufacturing facilities in Europe that serves 18 different nations.
Pylclari will be the most extensively used 18F-PSMA tracer in Europe once production is at full capacity, the nuclear medicine company claimed.
In May 2021, the US Food and Drug Administration (FDA) granted Lantheus a license to market Pylarify in the US.
In 2018, Curium acquired a license from Progenics, a Lantheus firm, for European rights.