Well, we had hoped that sometime this week, the FDA would have approved Zevalin as an initial treatment for NHL. Unfortunately, the decision has been delayed.
Right now, Zevalin is not approved for use as a first-time treatment for NHL; only after other treatments have failed can a patient try Zevalin. It's most often used (from what I can tell) as a kind of "last resort," after a failed stem cell transplant. Most often, but not exclusively. I wrote a few weeks ago about a woman named Betsy from the support group, who has written a book about her experiences with NHL. Her two attempts at chemo were unsuccessful, and then tried Zevalin, and has been in remission for almost 5 years.
Anyway, the FDA is considering an application for expanded use of Zevalin as a first treatment, before Rituxin or chemo or anything else. Clinical trials have been successful.
The FDA has asked for additional data from the trials. While it's not the best news (which would have been FDA approval, of course), it isn't the worst news, either. They aren't asking for additional clinical trials, just more data from the trials that have already been conducted. From what I understand, that's sometimes the case when the FDA is writing up the full prescribing label, so approval may come soon. Keep your fingers crossed.
The brief news story about Spectrum, the company that markets Zevalin, is here, but I think I've probably given you way more than that story....
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Hi Bob, This is Betsy, about whom you wrote. My remission now approaches 7 years! Keep up the good work! Betsy :))
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