CHMP Recommends Positive Opinion For Zevalin(R), [90Y]-ibritumomab Tiuxetan, In First Line Consolidation Therapy For Follicular Lymphoma

Main Category: Cancer / Oncology
Article Date: 26 Mar 2008 - 2:00 PDT

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Bayer Schering Pharma has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending Zevalin® ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma (FL) in Europe.

The recommendation is based on data from the First-line Indolent Trial (FIT) study. The FIT study shows nearly a 2 year improvement in progression free survival (PFS) in patients with advanced follicular lymphoma receiving [90Y]-ibritumomab tiuxetan vs, induction chemotherapy alone.1

[90Y]-ibritumomab tiuxetan is currently the only approved radio-labeled immunotherapy for adult patients with rituximab relapsed or refractory CD20-positive follicular B-cell Non-Hodgkin's Lymphoma (NHL) in Europe.2 It combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumour-destroying power of localised yttrium-90 radiation.

"This recommendation has the potential to provide clinicians with a treatment option that could help many of their patients with follicular lymphoma to extend life without disease progression" said Philip Ashman Business Unit Head - Oncology for Bayer Schering Pharma. "The CHMP's recommendation recognises the value of first-line consolidation therapy with Zevalin as a treatment regimen and the benefit it can offer to patients. The Cancer Reform Strategy sets out to build a world class cancer service in the NHS and as such, we look forward to further positive reception to these data and access for patients".

The CHMP's recommendation for [90Y]-ibritumomab tiuxetan will now be reviewed by the European Commission who will decide whether to grant marketing authorization for all EU member states for [90Y]-ibritumomab tiuxetan for this indication.

Non-Hodgkin's Lymphoma (NHL) and Follicular Lymphoma (FL)

Lymphoma is cancer of the lymphatic system,3 which is the human body's natural defence system against infection. NHL is the 6th most common cancer in the UK.4 There are many different types of NHL and FL is the most common.5 Every year around 10,000 people in the UK are diagnosed with NHL6 and it is estimated to cause around 4,450 deaths.7

[90Y]-ibritumomab tiuxetan

[90Y]-ibritumomab tiuxetan is a type of targeted cancer therapy called radioimmunotherapy. Radioimmunotherapy combines the use of a monoclonal antibody to target specific tumour cells within the body and a radioisotope to kill the targeted lymphoma cells, through several layers of tumour cells. [90Y]-ibritumomab tiuxetan combines the tumour-targeting ability of an anti-CD20 monoclonal antibody and the tumour-destroying ability of localized yttrium-90 [90-Y] radioisotope beta-radiation, resulting in a significantly higher overall response rate compared to non-radiolabelled immunotherapy alone.2 [90Y]-ibritumomab tiuxetan has been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin's lymphoma in UK since 2004.

The FIT Study

The [90Y]-ibritumomab tiuxetan FIT trial was a multinational, randomized Phase III trial in 414 patients, which investigated [90Y]-ibritumomab tiuxetan as first-line consolidation therapy given as a single therapeutic dose in patients with advanced (stage III or IV) follicular lymphoma who achieved at least a partial remission (PR) or unconfirmed complete response (CRu) or complete remission (CR) after receiving induction chemotherapy regimens.1 These data were presented at the American Society of Hematology (ASH) Annual Meeting in December 2007.

The FIT study1 showed a median PFS of 37 months with [90Y]-ibritumomab tiuxetan vs. 13.5 months in the control arm (p<0.0001, HR 0.463), an increase of 23.50 months. Subgroup analysis showed a median PFS of 29.7 months for [90Y]-ibritumomab tiuxetan vs. 6.3 months for control arm (p<0.0001) for patients in PR following induction therapy, and 54.6 months for [90Y]-ibritumomab tiuxetan vs. 29.9 months control arm (p=0.01) for patients in CR, respectively. [90Y]-ibritumomab tiuxetan consolidation of first remission after induction therapy in advanced stage FL is highly effective with a favourable toxicity profile. 77% of patients in PR converted to CR with 87% of patients in CR(u) and prolongation of PFS by 2 years.

About [90Y]-ibritumomab tiuxetan treatment

Rituximab pre-treatment is necessary to clear circulating B-cells, enabling [90Y]-ibritumomab tiuxetan to deliver radiation more specifically to the lymphomas.

Zevalin® ([90Y]-ibritumomab tiuxetan) injection is a registered trademark of Bayer Pharmaceuticals Corporation.

Bayer Schering Pharma

Bayer Schering Pharma is a leading, worldwide speciality pharmaceutical company. Its research and business activities are focussed on the fields of oncology, haematology & cardiology, diagnostic imaging, primary care, specialised therapeutics and women's healthcare. With innovative products and using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life of patients - a factor of particular importance in Oncology.

Bayer Schering Pharma's portfolio of oncology products includes treatments for both solid and haematological malignancies. Intensive research is ongoing as Bayer Schering Pharma strives to discover and advance therapeutic solutions for the benefit of all cancer patients.

For more information, please visit http://www.bayerscheringpharma.co.uk

Zevalin® ([90Y]-ibritumomab tiuxetan) injection is a registered trademark of Bayer Pharmaceuticals Corporation.

References:

1. FIT trial: [90Y]-ibritumomab tiuxetan (Zevalin) consolidation of first remission in advanced stage follicular NHL: First results of the international randomized Phase 3 First-line Indolent Trial (FIT) in 414 Patients. Abstract# 643. This data was presented at the American Society of Hematology (ASH) Annual Meeting in December 2007.

2. [90Y]-ibritumomab tiuxetan Summary of Product Characteristics http://emc.medicines.org.uk/ . Principle reference: Witzig et al. JCO, 2002: 20:2453-2463.

3. Cancer Help accessed 18 March 2008

4. CancerResearch UK accessed 19th March 2008.

5. Cancer help accessed 19th March 2008.

6. CancerResearch UK accessed 19th March 2008.

7. CancerResearch UK accessed 19th March 2008.

Bayer Schering Pharma

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