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▎ WuXi AppTec content team editor May 27, 2021, Lantheus Holdings announced that the US FDA has approved the listing of Pylarify (piflufolastat F18), a positron emission tomography (PET) imaging agent, to identify suspected metastasis or recurrence of prostate cancer .
Pylarify is a radiofluorinated small molecule imaging agent targeting prostate specific membrane antigen (PSMA).
Compared with traditional imaging detection, Pylarify PET imaging technology enables doctors to detect suspected metastatic or recurrent prostate cancer in any part of the body earlier and more accurately, so as to develop better treatment plans, which may have a huge impact on patients' lives .
Pylarify's approval is based on data from two key studies, OSPREY and CONDOR, enrolling a total of 593 patients.
The results of the study showed that in men who were at risk of metastatic prostate cancer before initial treatment, the specificity and positive predictive value (PPV) of Pylarify PET imaging were improved compared with traditional imaging.
In terms of safety and tolerability, Pylarify is well tolerated.
Only ≤2% of patients reported adverse reactions, including headache, dysgeusia, and fatigue.
In addition, 1 patient (0.
2%) with a history of allergic reactions reported delayed-type hypersensitivity.
Among male patients with localized prostate cancer who received initial radical treatment, up to 50% of patients may have disease recurrence within 10 years after treatment.
However, no matter in the early stage of cancer, or when the cancer recurs and spreads after initial treatment, conventional standard imaging examinations have obvious limitations.
PSMA is a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells, so it can show lymph node, bone and soft tissue metastasis to determine whether there is recurrent or metastatic prostate cancer.
For prostate cancer patients, Pylarify PET combines the accuracy of PET imaging, the accuracy of targeting PSMA and the clarity of F18 radioisotope, with superior diagnostic performance.
“The US FDA’s approval of Pylarify is a major milestone.
We believe that Pylarify represents a paradigm shift in the identification and management of suspected metastasis or recurrence of prostate cancer, and provides an earlier and more accurate disease detection method than conventional imaging.
Doctors, patients and their families can make more informed treatment decisions.
" said Ms.
Mary Anne Heino, President and CEO of Lantheus.
Reference: [1] Lantheus Receives US FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer.
May 27, 2021, from /news/home/20210527005291/en Note: This article aims to introduce the progress of medical and health research and is not a treatment plan recommendation.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
Pylarify is a radiofluorinated small molecule imaging agent targeting prostate specific membrane antigen (PSMA).
Compared with traditional imaging detection, Pylarify PET imaging technology enables doctors to detect suspected metastatic or recurrent prostate cancer in any part of the body earlier and more accurately, so as to develop better treatment plans, which may have a huge impact on patients' lives .
Pylarify's approval is based on data from two key studies, OSPREY and CONDOR, enrolling a total of 593 patients.
The results of the study showed that in men who were at risk of metastatic prostate cancer before initial treatment, the specificity and positive predictive value (PPV) of Pylarify PET imaging were improved compared with traditional imaging.
In terms of safety and tolerability, Pylarify is well tolerated.
Only ≤2% of patients reported adverse reactions, including headache, dysgeusia, and fatigue.
In addition, 1 patient (0.
2%) with a history of allergic reactions reported delayed-type hypersensitivity.
Among male patients with localized prostate cancer who received initial radical treatment, up to 50% of patients may have disease recurrence within 10 years after treatment.
However, no matter in the early stage of cancer, or when the cancer recurs and spreads after initial treatment, conventional standard imaging examinations have obvious limitations.
PSMA is a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells, so it can show lymph node, bone and soft tissue metastasis to determine whether there is recurrent or metastatic prostate cancer.
For prostate cancer patients, Pylarify PET combines the accuracy of PET imaging, the accuracy of targeting PSMA and the clarity of F18 radioisotope, with superior diagnostic performance.
“The US FDA’s approval of Pylarify is a major milestone.
We believe that Pylarify represents a paradigm shift in the identification and management of suspected metastasis or recurrence of prostate cancer, and provides an earlier and more accurate disease detection method than conventional imaging.
Doctors, patients and their families can make more informed treatment decisions.
" said Ms.
Mary Anne Heino, President and CEO of Lantheus.
Reference: [1] Lantheus Receives US FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer.
May 27, 2021, from /news/home/20210527005291/en Note: This article aims to introduce the progress of medical and health research and is not a treatment plan recommendation.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
