The most common adverse reactions include headache, altered taste, and fatigue.[4]
Piflufolastat F-18 was approved for medical use in the United States in May 2021.[1][6][4] It is the second PSMA-targeted PET imaging drug approved by the U.S. Food and Drug Administration (FDA).[4] The first approved PSMA-targeted PET imaging drug is Ga 68 PSMA-11.[4]
Piflufolastat F-18 is indicated for people with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or other therapy.[1][4] Piflufolastat F-18 is also indicated for people with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels.[1][4]
Historyedit
The safety and efficacy of piflufolastat F-18 were evaluated in two prospective clinical trials (trial 1/NCT02981368 and trial 2/NCT03739684) with a total of 593 men with prostate cancer who each received one injection of piflufolastat F-18.[4][7] In the first trial, a cohort of 268 participants with biopsy-proven prostate cancer underwent PET/CT scans performed with piflufolastat F-18.[4] These participants were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis.[4] Among the participants who proceeded to surgery, those with positive readings in the pelvic lymph nodes on piflufolastat F-18 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology.[4]
The second trial enrolled 208 participants who had rising serum prostate-specific antigen levels after initial prostate surgery or other definitive therapy, and thus had biochemical evidence of recurrent prostate cancer.[4] Prior to a single piflufolastat F-18 PET/CT scan, all of these participants had baseline conventional imaging performed that did not show definite spread of prostate cancer.[4] Piflufolastat F-18 PET detected at least one positive lesion in at least one body region (bone, prostate bed, pelvic lymph node, other lymph nodes, or soft tissue) in 60% of these participants.[4] In participants with positive piflufolastat F-18 PET readings who had correlative tissue pathology from biopsies, results from baseline or follow-up imaging by conventional methods, or serial PSA levels available for comparison, local recurrence or metastasis of prostate cancer was confirmed in an estimated 85% to 87% of cases, depending on the reader.[4] Thus, the second trial demonstrated that piflufolastat F-18 PET can detect sites of disease in participants with biochemical evidence of recurrent prostate cancer, thereby providing important information that may impact the approach to therapy.[4]
Trial 1 included two groups of participants, some with recently diagnosed prostate cancer and others with suspicious findings on standard tests.[7] Trial 2 included participants who were treated for prostate cancer before, but there was suspicion that the cancer was spreading because of rising prostate-specific antigen.[7] Participants in trial 2 and the recently diagnosed participants in trial 1 were studied for effectiveness of piflufolastat F-18, and all participants were studied for safety.[7] Trial 1 was conducted at eight sites in the United States and two sites in Canada, and trial 2 was conducted at thirteen sites in the United States and one site in Canada.[7] The number of participants representing efficacy findings may differ from the number of participants representing safety findings due to different pools of study participants analyzed for efficacy and safety.[7]
^ abcdef"Pylarify- piflufolastat f-18 injection". DailyMed. from the original on 13 September 2021. Retrieved 12 September 2021.
^"Pylclari EPAR". European Medicines Agency. 28 July 2023. Retrieved 4 August 2023.
^"Pylclari". Union Register of medicinal products. 25 July 2023. Retrieved 4 August 2023.
^ abcdefghijklmnopqr"FDA approves PSMA-targeted imaging drug for men with prostate cancer". U.S. Food and Drug Administration (FDA). 27 May 2021. from the original on 11 September 2021. Retrieved 12 September 2021. This article incorporates text from this source, which is in the public domain.
^"Drug Approval Package: Pylarify". U.S. Food and Drug Administration (FDA). 9 June 2021. from the original on 13 September 2021. Retrieved 12 September 2021.
^ abcdef"Drug Trials Snapshots: Pylarify". U.S. Food and Drug Administration. 26 May 2021. from the original on 28 July 2023. Retrieved 28 July 2023. This article incorporates text from this source, which is in the public domain.
This article incorporates public domain material from the United States Department of Health and Human Services.
External linksedit
"SDS Data Sheet" (PDF).
Clinical trial number NCT02981368 for "Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer (OSPREY)" at ClinicalTrials.gov
Clinical trial number NCT03739684 for "Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer (CONDOR)" at ClinicalTrials.gov
piflufolastat, sold, under, brand, name, pylarify, among, others, radioactive, diagnostic, agent, used, positron, emission, tomography, imaging, given, intravenous, injection, clinical, datatrade, namespylarify, pylclariother, names18f, dcfpylahfs, drugs, comm. Piflufolastat F 18 sold under the brand name Pylarify among others is a radioactive diagnostic agent used for positron emission tomography PET imaging 1 4 5 It is given by intravenous injection 1 4 Piflufolastat F 18Clinical dataTrade namesPylarify PylclariOther names18F DCFPyLAHFS Drugs comMicromedex Detailed Consumer InformationLicense dataUS DailyMed PiflufolastatRoutes ofadministrationIntravenousATC codeV09IX16 WHO Legal statusLegal statusUS only 1 EU Rx only 2 3 IdentifiersCAS Number1207181 29 0PubChem CID52950901DrugBankDB14805ChemSpider32702072UNII3934EF02T7KEGGD12132ChEMBLChEMBL4297334Chemical and physical dataFormulaC18H23 18F N4O8Molar mass441 4 g mol3D model JSmol Interactive imageSMILES OC O CC C H NC O N C H CCCCNC O C1 CC C 18F N C1 C O O C O OInChI InChI 1S C18H23FN4O8 c19 13 6 4 10 9 21 13 15 26 20 8 2 1 3 11 16 27 28 22 18 31 23 12 17 29 30 5 7 14 24 25 h4 6 9 11 12H 1 3 5 7 8H2 H 20 26 H 24 25 H 27 28 H 29 30 H2 22 23 31 t11 12 m0 s1 i19 1Key OLWVRJUNLXQDSP MVBOSPHXSA NThe most common adverse reactions include headache altered taste and fatigue 4 Piflufolastat F 18 was approved for medical use in the United States in May 2021 1 6 4 It is the second PSMA targeted PET imaging drug approved by the U S Food and Drug Administration FDA 4 The first approved PSMA targeted PET imaging drug is Ga 68 PSMA 11 4 Contents 1 Medical uses 2 History 3 References 4 External linksMedical uses editPiflufolastat F 18 is indicated for people with suspected prostate cancer metastasis when cancer cells spread from the place where they first formed to another part of the body who are potentially curable by surgery or other therapy 1 4 Piflufolastat F 18 is also indicated for people with suspected prostate cancer recurrence based on elevated serum prostate specific antigen PSA levels 1 4 History editThe safety and efficacy of piflufolastat F 18 were evaluated in two prospective clinical trials trial 1 NCT02981368 and trial 2 NCT03739684 with a total of 593 men with prostate cancer who each received one injection of piflufolastat F 18 4 7 In the first trial a cohort of 268 participants with biopsy proven prostate cancer underwent PET CT scans performed with piflufolastat F 18 4 These participants were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis 4 Among the participants who proceeded to surgery those with positive readings in the pelvic lymph nodes on piflufolastat F 18 PET had a clinically important rate of metastatic cancer confirmed by surgical pathology 4 The second trial enrolled 208 participants who had rising serum prostate specific antigen levels after initial prostate surgery or other definitive therapy and thus had biochemical evidence of recurrent prostate cancer 4 Prior to a single piflufolastat F 18 PET CT scan all of these participants had baseline conventional imaging performed that did not show definite spread of prostate cancer 4 Piflufolastat F 18 PET detected at least one positive lesion in at least one body region bone prostate bed pelvic lymph node other lymph nodes or soft tissue in 60 of these participants 4 In participants with positive piflufolastat F 18 PET readings who had correlative tissue pathology from biopsies results from baseline or follow up imaging by conventional methods or serial PSA levels available for comparison local recurrence or metastasis of prostate cancer was confirmed in an estimated 85 to 87 of cases depending on the reader 4 Thus the second trial demonstrated that piflufolastat F 18 PET can detect sites of disease in participants with biochemical evidence of recurrent prostate cancer thereby providing important information that may impact the approach to therapy 4 Trial 1 included two groups of participants some with recently diagnosed prostate cancer and others with suspicious findings on standard tests 7 Trial 2 included participants who were treated for prostate cancer before but there was suspicion that the cancer was spreading because of rising prostate specific antigen 7 Participants in trial 2 and the recently diagnosed participants in trial 1 were studied for effectiveness of piflufolastat F 18 and all participants were studied for safety 7 Trial 1 was conducted at eight sites in the United States and two sites in Canada and trial 2 was conducted at thirteen sites in the United States and one site in Canada 7 The number of participants representing efficacy findings may differ from the number of participants representing safety findings due to different pools of study participants analyzed for efficacy and safety 7 The US Food and Drug Administration FDA granted approval of Pylarify to Progenics Pharmaceuticals Inc 4 References edit a b c d e f Pylarify piflufolastat f 18 injection DailyMed Archived from the original on 13 September 2021 Retrieved 12 September 2021 Pylclari EPAR European Medicines Agency 28 July 2023 Retrieved 4 August 2023 Pylclari Union Register of medicinal products 25 July 2023 Retrieved 4 August 2023 a b c d e f g h i j k l m n o p q r FDA approves PSMA targeted imaging drug for men with prostate cancer U S Food and Drug Administration FDA 27 May 2021 Archived from the original on 11 September 2021 Retrieved 12 September 2021 nbsp This article incorporates text from this source which is in the public domain Keam SJ September 2021 Piflufolastat F 18 Diagnostic First Approval Molecular Diagnosis amp Therapy 25 5 647 656 doi 10 1007 s40291 021 00548 0 PMID 34292532 S2CID 236174886 Drug Approval Package Pylarify U S Food and Drug Administration FDA 9 June 2021 Archived from the original on 13 September 2021 Retrieved 12 September 2021 a b c d e f Drug Trials Snapshots Pylarify U S Food and Drug Administration 26 May 2021 Archived from the original on 28 July 2023 Retrieved 28 July 2023 nbsp This article incorporates text from this source which is in the public domain nbsp This article incorporates public domain material from the United States Department of Health and Human Services External links edit SDS Data Sheet PDF Clinical trial number NCT02981368 for Study of 18F DCFPyL PET CT Imaging in Patients With Prostate Cancer OSPREY at ClinicalTrials gov Clinical trial number NCT03739684 for Study of 18F DCFPyL PET CT Imaging in Patients With Suspected Recurrence of Prostate Cancer CONDOR at ClinicalTrials gov Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Piflufolastat F 18 amp oldid 1184512386, wikipedia, wiki, book, books, library,
