Nuclear medicine vendor Curium has submitted a marketing authorization application to the European Medicines Agency for clearance to market the PET radiotracer F-18 DCFPyL for diagnosing prostate cancer.
The submission comes two months after the completion of Curium's phase III Python trial. This trial compared prostate cancer detection rates, impact on patient management, and safety proﬁles between F-18 DCFPyL and F-18 Fluorocholine, which is currently approved for PET/CT imaging of prostate cancer in Europe.
The radiotracer was studied in patients with prostate cancer with first biochemical recurrence after initial definitive therapy with curative intent. The study successfully met the primary endpoint, with details to be presented at the 35th annual congress of the European Association of Nuclear Medicine to be held on 15 to 19 October in Barcelona, Curium said.
F-18 DCFPyL was approved by the U.S. Food and Drug Administration in May of 2021 and is commercially available as Pylarify and sold by Lantheus.