On March 7, 2024 Curium, a world leader in nuclear medicine, reported that the first commercial doses of PYLCLARI have been sold in Italy (Press release, Curium, MAR 7, 2024, View Source [SID1234640922]). PYLCLARI (INN: Piflufolastat (18F)) also known as (18 F)-DCFPyL, is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:
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Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Benoit Woessmer, PET Europe CEO at Curium commented, "We are thrilled that we have successfully started the commercial supply of PYLCLARI in Italy – supporting even more nuclear medicine physicians and their patients across Europe. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, today’s announcement underscores our priority on improving the choice of diagnostic modalities available to our customers – ultimately for the benefit of patients with prostate cancer."
In Italy, Curium currently manufactures PYLCLARI at its facilities in Milan, with plans to expand production to Pisa and Rome in the future to enable more patients to benefit.
Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI in the European Union. On 3rd February 2024 The Italian Medicines Agency (Agenzia Italiana del Farmaco) published the decision for PYLCLARI in Italy.
For more information about PYLCLARI: www.pylclari.com