FDA releases Zevalin data

Idec (IDPH) demonstrated efficacy in two Phase III trials of its Zevalin to treat non-Hodgkin's lymphoma (NHL), according to an FDA review released on Monday. The FDA's Oncologic Drugs Advisory Committee will review IDPH's BLA for Zevalin on Tuesday, Sept. 11. Zevalin is a 90-yttrium labeled anti- CD20 monoclonal antibody.

"Anti-tumor activity, as measured by durable objective tumor responses, was documented" in IDPH's two Phase III trials, stated the agency's clinical review. In one Phase III trial the overall response rate for Zevalin was 73%, compared to 47% for IDPH's Rituxan (p=0.002), the only FDA-approved agent indicated for use in relapsed or refractory low grade or follicular B cell NHL. In a second Phase III trial, chemotherapy-refractory and Rituxan-refractory NHL patients receiving Zevalin had a 58% overall response rate. ...