On November 16, 2023 Curium, a world leader in nuclear medicine, reported that in partnership with its exclusive distributor SYN Innovation Laboratories in Greece, the first patients in Greece have been injected with PYLCLARI (INN: Piflufolastat (18F) also known as (18 F)-DCFPyL, 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 (Press release, Curium, NOV 16, 2023, View Source [SID1234637734]):
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Primary staging of patients with high-risk PCa prior to initial curative therapy
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
Benoit Woessmer, PET Europe CEO at Curium commented, "We are thrilled that patients in Europe are finally able to benefit from PYLCLARI, and in particular those patients in Greece via our strong partnership with SYN Innovation Laboratories. As a world leader in nuclear medicine, Curium is pleased to be improving the choice of diagnostic tools available to physicians in Greece to diagnose prostate cancer – ultimately for the benefit of prostate cancer patients."
Savvas Thalasselis, Managing Director, SYN Innovation Laboratories SA commented: "Today’s announcement of the first dose of PYLCLARI in Greece is an important milestone for the detection of prostate cancer, in particular for the primary staging of patients with high-risk prostate cancer prior to initial curative therapy. Our long-term partnership with Curium has demonstrated our commitment to diagnosing patients with cancer, and we look forward to further supporting Curium with their future pipeline of diagnostic and therapeutic products."
Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI in the European Union. SYN Innovation Laboratories has been a partner with Curium since 2017, with exclusive manufacturing and distribution rights for Curium’s wide range of positron emission tomography products in Greece. SYN Innovation Laboratories will manufacture PYLCLARI at its facilities in Athens, Greece.