FDA committee to review IDEC's Zevalin

The US Food and Drug Administration's Oncologic Drugs Advisory Committeeis due to review IDEC Pharmaceutical's radioimmunotherapy Zevalin (ibritumomab tiuxetan) on September 11. The drug's proposed indication is for the treatment of relapsed or refractory, low-grade, follicular, CD20-positive transformed B-cell Hodgkin's lymphoma and Rituxan (rituximab)-refractory follicular NHL.

Earlier this year, the FDA asked IDEC for more clinical data on Zevalin, as well as more information on the chemistry, manufacturing and control of the drug, before it could consider approval (Marketletter May 21).

If approved, Zevalin would be one of the first radioimmuno-therapies available for commercial use in the USA. Schering-Plough, IDEC's partner, has marketing rights to Zevalin outside the USA and had its Marketing Authorization Application for the drug accepted for review by the European Medicines Evaluation Agency earlier this year.