On July 21, 2023 Curium, a world leader in nuclear medicine, reported the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fuoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer (Press release, Curium, JUL 21, 2023, View Source [SID1234633356]). The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Today’s announcement follows the May 2023 recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency to grant a marketing authorization for PYLCLARI (piflufolastat (18F)) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer – based on the Phase III PYTHON clinical trial conducted in Europe and the Phase III OSPREY and CONDOR clinical trials conducted in the U.S.
Dr. Daniela E. Oprea-Lager| Assoc. Professor in Nuclear Medicine, MD PhD, Amsterdam UMC (lead author of the PYTHON Manuscript submitted to the European Journal of Nuclear Medicine and Molecular Imaging) commented: "Adequate restaging of patients with biochemically relapsed prostate cancer is essential for guiding clinicians on how to choose the optimal treatment strategy with the maximum benefit for the patients. PYTHON trial demonstrates the superiority of [18F]DCFPyL above [18F]fluoromethylcholine PET/CT paving the way towards individualized therapy."
Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented: "[18F]fuoromethylcholine has been the current approved and established standard for PET/CT imaging of prostate cancer in Europe, and the publication of this manuscript validates our success in developing new diagnostic imaging solutions – as we continue on our journey to redefine the experience of cancer through our trusted legacy in nuclear medicine."
In the U.S., piflufolastat (18F) was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY and sold by Lantheus.
The PYTHON publication in European Journal of Nuclear Medicine and Molecular Imaging can be found here.
PYTHON Study
The PYTHON Study (NCT04734184) was a Phase III, European, multicenter, prospective cross-over trial, to evaluate and compare the detection rates, impact on patient management and safety profiles of [18F]DCFPyL and [18F]fuoromethylcholine, in patients with first biochemical recurrence after initial definitive therapy with curative intent. This study successfully met the primary endpoint.
About PYLARIFY (piflufolastat F 18, also known as [18F]DCFPyL) Injection
PYLARIFY (piflufolastat F 18) injection (also known as [18F]DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6
PYLARIFY is FDA-approved and commercialized in the U.S. by Lantheus. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2019.