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Home Industry News Biogen Idec reports phase III Rituxan data

Biogen Idec reports phase III Rituxan data

8th October 2008

Biogen Idec has announced the publication of phase III study data of Rituxan (rituximab) in combination with chemotherapy as a treatment for relapsed chronic lymphocytic leukaemia (CLL).

The company said the compound improved progression-free survival when administered together with fludarabine and cyclophosphamide chemotherapy, compared to treatment solely with chemotherapy.

Survival was assessed by investigators in patients with CD20-positive CLL who had previously received treatment.

The firm said the results of the Reach trial showed no new or unexpected safety signals and will be submitted for presentation at a medical meeting in the future.

Rituxan is an antibody first approved by the US Food and Drug Administration in 1997 as a treatment for low-grade or follicular, relapsed or refractory, CD20-positive B-cell non-Hodgkin’s lymphoma and approved in the EU as MabThera a year later.

Cecil Pickett, president of research and development at Biogen Idec, said: “Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy.”

He added the results of the Reach trial are promising and – when confirmed by an independent review – will result in the company applying for regulatory approval for Rituxan in this indication.

Last month, Biogen Idec presented new data on a range of drugs for multiple sclerosis, including Rituxan.

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