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news.Cell Therapeutics, a biopharmaceutical company, has submitted a supplemental biologics license application to the FDA for use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma.
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If approved, Zevalin would be the only radioimmunotherapy in the US with approval for use as first-line consolidation therapy. The company has requested priority review, which if granted, would result in a six month review period.
Cell Therapeutics (CTI) has gained access to the first-line indolent trial data through an agreement with Bayer Schering Pharma, Germany 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 non-Hodgkin’s lymphoma (NHL), including patients with rituximab refractory follicular NHL.
James Bianco, CEO of Cell Therapeutics, said: “If the supplemental biologics license application (sBLA) is approved there would be approximately 18,000 additional patients that currently receive first-line treatment that would potentially be eligible to use Zevalin under the proposed expanded label.
“The submission is a major milestone for CTI as approval could have an important impact on the treatment of follicular non-Hodgkin’s lymphoma and we would expect it to significantly enhance the value of the product for CTI and our shareholders.”