Cell Therapeutics files sBLA for Zevalin use in consolidation therapy

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Cell Therapeutics, a biopharmaceutical company that develops oncology products, has submitted a supplemental biologics license application (sBLA) for using Zevalin as consolidation therapy in patients with follicular non-Hodgkin's lymphoma (NHL).

The Seattle-based company said Zevalin, if approved, would be the only radioimmunotherapy in the United States with approval to be used as first-line consolidation therapy.

Zevalin is currently FDA-approved for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, 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.