InvestorsHub Logo
icon url

dia76ca

10/25/12 9:49 PM

#100696 RE: freethemice #100695

My understanding is that some of the regulations concerning Zevalin use have recently been reduced. Here is some information from a interested website about the first of two doses.

"The first dose is a dose of Rituxan but at a lower dose than usual. It is given at 250mg/m2 instead of the usual 375mg/m2. The primary purpose of this dose of Rituxan is to bind to sites in the peripheral blood and marrow and clean those up so that the Zevalin dose can go to the more important tumour sites.

Next may come the imagining dose of the antibody Ibritumomab but with Indium-111 attached instead of Yttrium-90. Originally this dose was designed to allow imaging studies to determine the proper dose. This is because Yttrium only emits beta radiation but does not emit gamma radiation. Beta radiation cannot be imaged on scanners. Using Indium which emits gamma radiation allowed for imaging studies to determine where the Zevalin was going and what the optimal dose would be. Recent data shows that the dose appears to be consistent for all patients and is therefore based on patient weight and platelet count.

In Canada the Indium step is skipped since it is not required. The United States FDA announced in November 2011 the Indium step will be eliminated. This will make the treatment much more convenient for the patient, and help reduce the cost as well.

In Switzerland and Japan the Indium dose may still be given and one or more imaging scans may be performed over the next 2-9 days to verify that the biodistribution of Zevalin is as expected.

Recently a study* has been published showing that the Indium step has no value and can be safely eliminated."

*Discriminatory power of the 111-indium scan (111-In) in the prediction of altered biodistribution of radio-immunoconjugate in the 90-yttrium ibritumomab tiuxetan therapeutic regimen: Meta-analysis of five clinical trials and 9 years of post-approval safety data