Piflufolastat F 18: Diagnostic First Approval

Keam, Susan J.

doi:10.1007/s40291-021-00548-0

Cited by 40 publications

(37 citation statements)

References 32 publications

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“…Piflufolastat F18 injection is indicated for positron emission tomography (PET) o prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels [45,46]. It is the second generation of the PSMA-based PET drug for the same diagnostic purpose after 68 Ga gozetotide (Figure 9), which was approved by the FDA in 2020 [47,48] The PMSA-11 antigen moiety drives the drug to PSMA, which is a membrane glycoprotein expressed in several body tissues, especially in the prostate, and overexpressed in tumor cells [48].…”

Section: X For Peer Reviewmentioning

confidence: 99%

“…Piflufolastat F18 is administered intravenously and has a half-life of 1010 min, thus effectively enabling the imaging and diagnosis of the lesions in 60 min after Piflufolastat F18 injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels [45,46]. It is the second generation of the PSMA-based PET drug for the same diagnostic purpose after 68 Ga gozetotide (Figure 9), which was approved by the FDA in 2020 [47,48].…”

Section: X For Peer Reviewmentioning

confidence: 99%

“…The PMSA-11 antigen moiety drives the drug to PSMA, which is a membrane glycoprotein expressed in several body tissues, especially in the prostate, and overexpressed in tumor cells [48].…”

Section: X For Peer Reviewmentioning

confidence: 99%

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2021 FDA TIDES (Peptides and Oligonucleotides) Harvest

et al. 2022

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From the medical, pharmaceutical, and social perspectives, 2021 has been a year dominated by the COVID-19 pandemic. However, despite this global health crisis, the pharmaceutical industry has continued its endeavors, and 2021 could be considered an excellent year in terms of the drugs accepted by the US Food and Drug Administration (FDA). Thus, during this year, the FDA has approved 50 novel drugs, of which 36 are new chemical entities and 14 biologics. It has also authorized 10 TIDES (8 peptides, 2 oligonucleotides), in addition to 2 antibody-drug conjugates (ADCs) whose structures contain peptides. Thus, TIDES have accounted for about 24% of the approvals in the various drug categories. Importantly, this percentage has surpassed the figure in 2020 (10%), thus reflecting the remarkable success of TIDES. In this review, the approved TIDE-based drugs are analyzed on the basis of their chemical structure, medical target, mode of action, administration route, and adverse effects.

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Section: X For Peer Reviewmentioning

confidence: 99%

Section: X For Peer Reviewmentioning

confidence: 99%

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2021 FDA TIDES (Peptides and Oligonucleotides) Harvest

et al. 2022

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“…In the recent years, multiple 68 Ga-and 18 F-labelled PSMA-targeting radiotracers have been introduced and recommended in several guidelines (10)(11)(12). Furthermore, 68 Ga-PSMA-11 and 18 F-DCFPyL received recent FDA-approval for imaging of BCR (13,14).…”

Section: Psma-pet For Recurrent Pcamentioning

confidence: 99%

Editorial: Exploring the Potential of PSMA-PET Imaging on Personalized Prostate Cancer Treatment

et al. 2022

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Editorial on the Research TopicExploring the Potential of PSMA-PET Imaging on Personalized Prostate Cancer Treatment INTRODUCTIONProstate cancer (PCa) is the second most frequent cancer diagnosis made in men worldwide (1). Accurate and reliable diagnostic medical imaging is a frequent prerequisite for personalized treatment approaches in patients with PCa by enabling, in part, (i) understanding extent of disease, (ii) accurate segmentation of PCa lesions and, (iii) non-invasive tumor characterization, for example, using radiomics or artificial intelligence tools (2).Prostate Specific Membrane Antigen (PSMA) has been found to be selectively overexpressed in PCa cells (3) and can be traced by radio-labelled peptide ligands in positron emission tomography (PSMA-PET). First studies suggested excellent diagnostic accuracy and a major impact on therapeutic approaches for PSMA-PET in newly diagnosed (4), recurrent (5) or metastatic PCa patients (4). The goal of this Research Topic was to concentrate scientific contributions on the growing evidence of integrating PSMA-PET imaging in personalized PCa treatment concepts.The Research Topic accepted 15 articles including a total of 126 authors, demonstrating the growing interest in the field of PSMA-PET imaging. The manuscripts of the Research Topic can be divided into the following topics.

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“…It seems that [ 18 F]PSMA-1007 is more sensitive than [ 18 F]FDCFPyL for N-staging. It may be due to the urinary elimination of [ 18 F]FDCFPyL [ 128 ], which may obscure some small LNs in the pelvic cavity.…”

Section: Targeting Agentsmentioning

confidence: 99%

Molecular Imaging in Primary Staging of Prostate Cancer Patients: Current Aspects and Future Trends

Manafi‐Farid

Ranjbar

Araghi

et al. 2021

Cancers

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Accurate primary staging is the cornerstone in all malignancies. Different morphological imaging modalities are employed in the evaluation of prostate cancer (PCa). Regardless of all developments in imaging, invasive histopathologic evaluation is still the standard method for the detection and staging of the primary PCa. Magnetic resonance imaging (MRI) and computed tomography (CT) play crucial roles; however, functional imaging provides additional valuable information, and it is gaining ever-growing acceptance in the management of PCa. Targeted imaging with different radiotracers has remarkably evolved in the past two decades. [111In]In-capromab pendetide scintigraphy was a new approach in the management of PCa. Afterwards, positron emission tomography (PET) tracers such as [11C/18F]choline and [11C]acetate were developed. Nevertheless, none found a role in the primary staging. By introduction of the highly sensitive small molecule prostate-specific membrane antigen (PSMA) PET/CT, as well as recent developments in MRI and hybrid PET/MRI systems, non-invasive staging of PCa is being contemplated. Several studies investigated the role of these sophisticated modalities in the primary staging of PCa, showing promising results. Here, we recapitulate the role of targeted functional imaging. We briefly mention the most popular radiotracers, their diagnostic accuracy in the primary staging of PCa, and impact on patient management.

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Piflufolastat F 18: Diagnostic First Approval

Cited by 40 publications

References 32 publications

2021 FDA TIDES (Peptides and Oligonucleotides) Harvest

2021 FDA TIDES (Peptides and Oligonucleotides) Harvest

Editorial: Exploring the Potential of PSMA-PET Imaging on Personalized Prostate Cancer Treatment

Molecular Imaging in Primary Staging of Prostate Cancer Patients: Current Aspects and Future Trends

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