FDA asks for more data on Zevalin

The US Food and Drug Administration has told IDEC Pharmaceuticals thatit needs more data on the firm's anti-CD20 radioimmunotherapy for refractory or relapsed B-cell non-Hodgkin's lymphoma, Zevalin (ibritumomab tiuxetan), before it can consider approving the drug. Nevertheless, IDEC says that it does not believe it will need to conduct an additional clinical trial to provide the outstanding information, which relates to clinical data, as well as chemistry, manufacturing and controls issues.

IDEC said it hopes to submit the data to the FDA by mid-July, which would keep the company on track for approval and launch before the end of the year. If approved, Zevalin will join Rituxan (rituximab) in IDEC's portfolio of approved drugs. Rituxan is also approved as a treatment for NHL and achieved sales of $168 million in the USA during the first quarter of this year.

Observers have suggested that Zevalin has the potential to eclipse Rituxan in terms of its importance to IDEC, as the firm will be able to bank more of the profits from the drug. Rituxan is sold in the USA through a joint venture with Genentech, but IDEC plans to self-market Zevalin in the USA, with Schering AG selling it elsewhere. Peak Zevalin sales are estimated to reach $300-$400 million.