Cell Therapeutics has announced that following a meeting with the FDA data from the first-line indolent trial would be sufficient to support a submission for a supplemental biologics license application.

The supplemental biologics license application (sBLA) will propose a label expansion to include use of the Zevalin therapeutic regimen ((90Y)-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma (NHL).

The company plans to submit the sBLA in the fourth quarter of 2008 and request priority review, which if granted, would result in a six-month review period. Cell Therapeutics (CTI) gained access to the first-line indolent trial (Fit) data through an agreement with Bayer Schering Pharma who used the data to obtain approval for Zevalin as first-line consolidation treatment in Europe.

Zevalin is currently approved in the US for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using an endpoint of overall response rate, which is a surrogate for progression free survival.

James Bianco, CEO of CTI, said: "We are pleased with the collegial interaction with the FDA and their guidance on our plan for submitting the Fit trial results to expand the Zevalin label. Label expansion for first-line indication would make this important treatment option available to the tens of thousands of patients who may benefit."