Idec Zevalin recommended for approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's Oncologic Drugs Advisory Committee on Sept. 11 unanimously recommends approval of Idec's Zevalin (ibritumomab) to treat low-grade, follicular non-Hodgkin's lymphoma in patients refractory to Genentech/Idec's Rituxan (rituximab). The committee was opposed to standard approval for patients who are not refractory to Rituxan, but voted 13 to 2 in support of accelerated approval for such patients