Investor Update
Basel, 18 November
US FDA issues complete response letter for Rituxan/MabThera for chronic lymphocytic leukaemia
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) issued a complete response to Genentech, a wholly-owned member of the Roche Group, and Biogen Idec (Nasdaq: BIIB) on the companies’ applications for Rituxan/MabThera (rituximab) plus fludarabine and cyclophosphamide (FC) chemotherapy for the treatment of for the treatment of patients with previously untreated and previously treated chronic lymphocytic leukaemia (CLL).
The FDA has not requested any new data to complete its review of these applications. Genentech and Biogen Idec will continue final label discussions with the FDA and are committed to making Rituxan/MabThera in combination with FC an FDA-approved option for people with CLL.
CLL is the most common type of leukaemia in adults, accounting for approximately 30-40% of all forms of leukaemia in Western countries. Overall incidence of CLL is around three per 100,000 and is 30% more common in men than women. 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).
Earlier this year, MabThera was approved in the European Union in combination with chemotherapy in previously untreated patients with advanced CLL and those with relapsed or refractory CLL. In addition, Rituxan/MabThera is already standard of care for Non-Hodgkin’s lymphoma, a group of cancers that affect the lymphatic system.
Rituxan/MabThera Efficacy in Chronic Lymphocytic Leukaemia
The US applications are based on data from two Phase III studies, CLL8 and REACH. Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. REACH was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated (relapsed or refractory) CD20-positive CLL who had not previously received Rituxan/MabThera (Rituxan-naïve). Both studies evaluated Rituxan/MabThera plus FC chemotherapy compared with FC chemotherapy alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response and toxicity. No new or unexpected safety signals were observed in either study.
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 defences 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 indicated in the EU:
- For the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukaemia (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 oncology, Rituxan/MabThera is 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 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 (cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP)) or other anthracycline-based chemotherapy regimens
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 tumour necrosis factor (TNF) inhibitor therapies.
MabThera is known as Rituxan in the United States, Japan and Canada. Over 1.7 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 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 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 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.
All trademarks used or mentioned in this release are protected by law.
Acronyms
CHOP - cyclophosphamide, doxorubicin, vincristine and prednisolone chemotherapy
CLL - chronic lymphocytic leukaemia
CNS - central nervous system
CVP - cyclophosphamide, vincristine, prednisolone chemotherapy
DMAR - Ddisease-modifying anti-rheumatic drugs
FC - fludarabine and cyclophosphamide chemotherapy
FDA - US Food and Drug Administration
NHL - non-Hodgkin’s lymphoma
PFS - progression-free survival
R&D - research and development
TNF - tumour necrosis factor