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Published on 15 May 2008

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Zevalin licenced for first line consolidation therapy

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Zevalin ([90Y]-ibritumomab tiuxetan) can now be used as first-line consolidation therapy after remission induction in previously untreated patients with follicular lymphoma (FL).

The European Commission (EC) decision is based on data from the First-line Indolent Trial (FIT) study which showed almost a two-year improvement in progression free survival (PFS) in patients with advanced FL receiving consolidation treatment with [90Y]-ibritumomab tiuxetan, compared to those patients receiving induction chemotherapy alone.

Consolidation treatment is a cancer therapy given after the induction therapy (usually chemotherapy) and aims to improve the initial effect of an induction therapy.

“The focus and hope of treatment of follicular lymphoma patients is to achieve remission,” said Professor Tim Illidge, a Consultant in Oncology at the Christie Hospital in Manchester and Zevalin investigator. “First line consolidation treatment with Zevalin offers clear benefits for patients in improving the quality of their response and therefore extending their remission period”

“The availability of Zevalin as consolidation therapy provides clinicians with an innovative treatment option that could help follicular lymphoma patients extend life without disease progression.”

[90Y]-ibritumomab tiuxetan combines the tumour-targeting ability of an anti-CD20 monoclonal antibody and the tumour-destroying power of localised yttrium-90 radiation.3

“For anyone diagnosed with cancer any additional time with family is hugely important and being able to offer follicular lymphoma patients the chance of a survival advantage cannot be under estimated“, said Melanie Burfitt from the Lymphoma Association.

“We look forward to continued clinical developments in this area and hope that patients’ continue to be able to access and benefit from the improvements they offer.”

“It is particularly impressive that with one single infusion of Zevalin, we have achieved prolongation of median progression free survival by two years, with a favorable toxicity profile,” said Professor Anton Hagenbeek, Academic Medical Centre, Amsterdam, the Netherlands, lead investigator of the FIT trial.

“The results also show that radioimmunotherapy is a very effective single agent in the treatment of follicular lymphoma.”

Zevalin was originally approved in 2004 for adult patients with rituximab relapsed or refractory CD20-positive follicular B-cell NHL in Europe. It remains the only licensed radioimmunotherapy in this indication.

The recent decision by the European Commission to extend marketing authorisation will provide a much wider group of patients with the chance of prolonged remission and improved response to treatment.

The Bayer Group



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