EU launch of NHL drug Zevalin delayed

Zevalin (ibritumomab tiuxetan), the radioimmunotherapy for non-Hodgkin'slymphoma originated by IDEC Pharmaceuticals, looks set to be delayed for up to a year in Europe due to "certain technical compliance issues at the fill/finish provider," according to the firm. The product had been scheduled for a launch in Europe by local licensee Schering AG in the second half of this year but, in a statement, Schering revealed that it is now hoping to introduce it "by the second half of 2003."

Schering and IDEC stressed that the clinical efficacy of the radioimmunotherapy, which consists of an anti-CD12 monoclonal antibody linked to the radioisotope Yttrium 90, is not in question. Zevalin has already been approved for marketing by the US Food and Drug Administration, and became the first radioimmunotherapy to be introduced for NHL on its launch in March (Marketletter April 1). Schering said that changes have to be made to the manufacturing process for Zevalin in order to bring it into alignment with European Union regulations.

- Meantime, rival NHL treatment Bexxar (tositumomab) from Corixa and GlaxoSmithKline looks set to get another crack at approval in the USA, after being rejected by the FDA (Marketletter March 18). The go-ahead has now been given for a new advisory panel meeting to hear an appeal, due to take place before the end of the year.