FDA sets decision date for Zevalin in lymphoma consolidation

Consolidation. Never thought the word could be sexy but as a concept it's huge in oncology right now. The concept is this: after the patient is finished with initial chemo they move on to chemo "lite" to consolidate the gains they made with initial treatment. The vexing problem of lymphoma and a few other cancers is this: we can usually induce a remission but the disease often comes back and is much harder to treat when it does. So the strategy is becoming: find a treatment that will prolong the remission if not make it permanent. FDA approved Alimta two weeks ago for this very purpose. There has been consistent evidence of benefit from the clinical trials for a few years. In the case of Zevalin there were persuasive results presented at the 2007 ASH. Zevalin prolongs remission by quite a bit of time: almost three years median versus one year with conventional treatment. This was in patients with advanced follicular lymphoma. The FDA is not expected to rule on the application for a new indication until September but they did seem to accept the clinical trial data as useable (this was the hurdle Erbitux failed to clear--the alleged early alert to Martha Stewart led to her Federal obstruction of justice charges).