Follicular lymphoma: EU approval for Zevalin® as First-Line Consolidation Treatment

The Bayer GroupThe European Commission has extended the marketing authorization for Zevalin® ([90Y]-ibritumomab tiuxetan) in Europe. Zevalin can now be used in the course of a first-line therapy after remission induction in previously untreated patients with follicular lymphoma. The aim of such a consolidation therapy is the improvement of the effect of an initial induction therapy. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. Zevalin was initially approved in Europe in 2004. It combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumor-destroying power of localized yttrium-90 radiation. Follicular lymphoma is one of the most common types of Non-Hodgkin's Lymphoma, a tumor of the lymphatic system.

"This news means that many patients with follicular lymphoma will now have access to Zevalin's proven clinical benefits," said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. "The approval in first-line consolidation treatment will also help us to further exploit the potential of Zevalin."

The decision by the European Commission to grant extended marketing authorization to Zevalin is based on data from the pivotal Phase III First-Line Indolent Trial (FIT). It showed that Zevalin, when used as first-line consolidation therapy, significantly prolonged the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001). The data were presented for the first time at the 49th Annual Meeting of the American Society of Hematology (ASH) in December 2007.

"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."

About Zevalin - First-line Consolidation Therapy
Consolidation therapy is a treatment regimen given after a patient responds to initial first-line induction therapy (e.g. chemotherapy). The aim of consolidation therapy is to rapidly improve the quality of a patient's response, thereby extending the response duration.

About the FIT study
The Zevalin FIT study (First-line Indolent Trial) is a multinational, randomized, Phase III trial to investigate Zevalin as first-line consolidation therapy, given as a single therapeutic dose, in patients with advanced (stage III or IV) follicular lymphoma who achieved a partial remission or a complete remission after receiving standard first-line chemotherapy regimens. The objective of the FIT study is the evaluation of benefit and safety of consolidation with Zevalin after first-line therapy in follicular lymphoma patients, one of the most common types of Non-Hodgkin’s Lymphoma.

About Zevalin® - the immunotherapy with yttrium-90 Zevalin® is currently approved in more than 40 countries for the treatment of B-cell non-Hodgkin's lymphoma, including Europe, countries in Latin America and, amongst others in Asia, Japan. In Europe, Zevalin is now indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. Zevalin has also been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin's lymphoma since 2004.

Zevalin combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumor-destroying power of localized yttrium-90 radiation.

The radiolabeled antibodies can specifically bind to the tumor, thereby killing targeted and also neighboring lymphoma cells, and thus destroying the tumor through several layers of tumor cells. The treatment ensures high bio-availability at tumor sites and prevents the radioactivity from being distributed through the body by circulating lymphocytes.

Bayer Schering Pharma AG has exclusive rights to Zevalin in all countries of the world except the U.S.

About Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma (NHL) is a type of malignant disease that occurs within the lymphatic system. NHL is the fifth most common cancer after breast, prostate, lung, and colon cancer. It originates from lymphocytes, a type of white blood cells, which can be divided into two main types, B lymphocytes and T lymphocytes (also called B-cells and T-cells).

Non-Hodgkin's lymphomas can be divided into two general clinical categories: indolent lymphomas, mainly typified as follicular lymphomas, which tend to grow relatively slowly; and aggressive lymphomas, mainly typified as diffuse large B-cell lymphomas (DLBCL), which grow more rapidly.

Follicular lymphoma (FL) is one of the most common types of indolent NHL, accounting for 70% of all indolent cases. The overall prevalence of NHL in the European Union is approximately 230,000, with an annual incidence of about 70,000. Approximately 18,500 new cases of FL are diagnosed annually in the U.S. It is a long-lasting disease and is difficult to treat.

About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG.

Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

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