HER2 Support Group Forums - View Single Post - FDA approves new gadolinium contrast agent for MRIs which shows CNS lesions and their

Lani · 03-21-2013, 11:11 AM

relationship to an open/intact blood-brain barrier better than other agents

This opens up the possibility of studying whether given one or another agent during periods the BBB is "open" is better, developing agents which "open" blood brain barrier, determine if treatment is working, if lesions seen are mets or scarring fro previous procedures etc

Can't help but thinking this should accelerate finding effective/best treatments for brain mets

FDA Approvals
FDA Approves New Gadolinium-Based MRI Agent
Robert Lowes
Mar 20, 2013

A gadolinium-based contrast agent (GBCA) for MRI procedures already used in dozens of other countries received approval today from the US Food and Drug Administration (FDA), the agency announced.

The agent, gadoterate meglumine (Dotarem, Guerbet LLC), helps radiologists identify abnormalities of the central nervous system (CNS), according to the FDA. It is indicated for MRIs of the brain, spine, and associated tissues in patients aged 2 years or older.

Guerbet has described gadoterate meglumine as the only macrocyclic and ionic GBCA for intravenous use with MRI in the indicated tissues "to detect and visualize areas with disruption of the blood-brain barrier and/or abnormal vascularity."

The FDA established the safety and efficacy of gadoterate meglumine in a clinical trial involving 245 adult patients and 38 pediatric patients with suspected CNS abnormalities. They each received 2 MRI scans — one without gadoterate meglumine, and one with this agent. The study found that the agent helped radiologists better visualize CNS lesions and identify their borders. A clinical trial in which the patients had previously defined CNS abnormalities produced similar results.

Like other GBCAs, gadoterate meglumine will carry a boxed warning about the risk for nephrogenic systemic fibrosis in certain patients with kidney disease.

No common adverse events for gadoterate meglumine emerged in clinical trials. The adverse events most frequently reported were nausea, headache, pain or coldness at the injection site, and a burning sensation.

The manufacturer states on its Web site that gadoterate meglumine, first marketed in France in 1989, is available in roughly 60 countries.

The FDA said in a press release that gadoterate meglumine becomes the seventh GBCA it has approved for MRIs of the CNS.

03-21-2013, 11:11 AM	#1
Lani Senior Member Join Date: Mar 2006 Posts: 4,778	FDA approves new gadolinium contrast agent for MRIs which shows CNS lesions and their relationship to an open/intact blood-brain barrier better than other agents This opens up the possibility of studying whether given one or another agent during periods the BBB is "open" is better, developing agents which "open" blood brain barrier, determine if treatment is working, if lesions seen are mets or scarring fro previous procedures etc Can't help but thinking this should accelerate finding effective/best treatments for brain mets FDA Approvals FDA Approves New Gadolinium-Based MRI Agent Robert Lowes Mar 20, 2013 A gadolinium-based contrast agent (GBCA) for MRI procedures already used in dozens of other countries received approval today from the US Food and Drug Administration (FDA), the agency announced. The agent, gadoterate meglumine (Dotarem, Guerbet LLC), helps radiologists identify abnormalities of the central nervous system (CNS), according to the FDA. It is indicated for MRIs of the brain, spine, and associated tissues in patients aged 2 years or older. Guerbet has described gadoterate meglumine as the only macrocyclic and ionic GBCA for intravenous use with MRI in the indicated tissues "to detect and visualize areas with disruption of the blood-brain barrier and/or abnormal vascularity." The FDA established the safety and efficacy of gadoterate meglumine in a clinical trial involving 245 adult patients and 38 pediatric patients with suspected CNS abnormalities. They each received 2 MRI scans — one without gadoterate meglumine, and one with this agent. The study found that the agent helped radiologists better visualize CNS lesions and identify their borders. A clinical trial in which the patients had previously defined CNS abnormalities produced similar results. Like other GBCAs, gadoterate meglumine will carry a boxed warning about the risk for nephrogenic systemic fibrosis in certain patients with kidney disease. No common adverse events for gadoterate meglumine emerged in clinical trials. The adverse events most frequently reported were nausea, headache, pain or coldness at the injection site, and a burning sensation. The manufacturer states on its Web site that gadoterate meglumine, first marketed in France in 1989, is available in roughly 60 countries. The FDA said in a press release that gadoterate meglumine becomes the seventh GBCA it has approved for MRIs of the CNS.