US FDA approves Rituxan/MabThera for the most common type of adult leukemia

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved Rituxan/MabThera (rituximab) plus fludarabine and cyclophosphamide (FC) chemotherapy for people with either previously untreated (first-line) or previously treated (relapsed or refractory) CD20-positive chronic lymphocytic leukemia (CLL).

CLL is the most common type of leukemia in adults, accounting for approximately 30-40% of all forms of leukemia in Western countries. Overall incidence of CLL is around four per 100,000 and is 50% more common in men than in women1. CLL is currently considered incurable; therefore the aim of treatment is to control the disease by managing symptoms and extending the time patients live without their disease worsening (progression-free survival or PFS).

Pivotal studies have shown that patients with CLL who are treated with Rituxan/MabThera plus chemotherapy live significantly longer without their disease progressing than those treated with chemotherapy alone. In addition, new data from one of the pivotal trials show that first-line treatment with Rituxan/MabThera (plus chemotherapy) improves overall survival, positively affecting for the first time the natural course of CLL. These latter data from the pivotal CLL8 phase III study were presented in December 2009 at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans, LA (USA).

“The approval of Rituxan/MabThera in combination with chemotherapy for the treatment of CLL gives hope to the thousands of US patients living with this devastating disease, and reinforces the role that this medicine plays in treating blood cancers,” said Pascal Soriot, COO Roche Pharmaceuticals Division. “Rituxan/MabThera is already standard of care for Non-Hodgkin’s lymphoma, a group of cancers that affect the lymphatic system.”

In 2009, Rituxan/MabThera was approved in the European Union for use in combination with chemotherapy in previously untreated patients (first line) with advanced CLL and those with relapsed or refractory CLL.
About Rituxan/MabThera

Rituxan/MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body’s natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

In oncology, Rituxan/MabThera is also indicated in the US:

* For the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
* For the treatment of NHL for the following:
* Previously untreated follicular, CD20-positive, B-cell NHL in combination with cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy
* Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent, after first-line CVP chemotherapy
* Previously untreated diffuse large B-cell, CD20-positive, NHL in combination with standard chemotherapy (CHOP) or other anthracycline-based chemotherapy regimens

In oncology, Rituxan/MabThera is indicated in the EU:

* For the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL) in combination with chemotherapy
* For the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
* As maintenance therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without Rituxan/MabThera
* For the treatment of patients with CD20-positive diffuse large B cell non-Hodgkin’s lymphoma (NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy
* As monotherapy for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy

In addition, in rheumatology Rituxan/MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumor necrosis factor (TNF) inhibitor therapies.

MabThera is known as Rituxan in the United States, Japan and Canada. About 1.9 million patient exposures with Rituxan/MabThera in hematological malignancies (lymphomas and cancers having their origin in blood cells) have been recorded worldwide since its launch.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets Rituxan/MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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1) Surveillance and Epidemiology and End Results (SEER), http://seer.cancer.gov/statfacts/html/clyl.html