CHMP recommends EU approval of a new formulation of Roche’s MabThera for patients with non-Hodgkin lymphoma

Basel, 24 January 2014

Subcutaneous formulation to be administered under the skin over approximately five minutes compared with 2.5 hours with the current intravenous formulation

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL).

“We are excited the MabThera SC data confirm the efficacy and safety of a significantly shortened treatment time,“ said Sandra Horning, M.D., Chief Medical Officer and Head, Global Product Development. “We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike.”

Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation can be delivered over approximately five minutes and comes as a ready-to-use, fixed dose, which reduces pharmacy preparation time and overall impact on hospital resources.

The CHMP opinion is based primarily on data from the phase III SABRINA study. Roche expects a final decision from the European Commission in the coming months.

About MabThera

MabThera is a therapeutic monoclonal 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.

MabThera (Rituxan in the United States), discovered by Biogen Idec, first received FDA approval for the treatment of relapsed indolent NHL in 1997 and was the first targeted cancer medicine approved by the U.S. Food and Drug Administration (FDA). MabThera was approved in the EU in June 1998. For more than 15 years, the efficacy and safety of MabThera has been documented in more than 300 phase II/III clinical studies. MabThera has been approved for the treatment of several blood cancers, specifically, certain types of NHL and for chronic lymphocytic leukemia (CLL). In that time, MabThera has been used to treat more than 2.7 million people with specific blood cancers since its launch. It continues to be studied in other types of blood cancers and disease areas where CD20-positive cells are believed to play a role.

MabThera is known as Rituxan in the United States, Japan and Canada. Genentech, a member of the Roche Group, and Biogen Idec collaborate on 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 non-Hodgkin lymphoma

There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL).

Non-Hodgkin lymphomas (NHL) are difficult-to-treat and represent approximately 84% of lymphoma diagnoses1. NHL was responsible for over 200,000 annual deaths worldwide in 20102.

Lymphomas are a cancer of the lymphatic system (composed of lymph vessels, lymph nodes and organs) which helps to keep the body fluid levels balanced and to defend the body against infectious diseases. Lymphoma develops when white blood cells (usually B-lymphocytes) in the lymph fluid become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen. Some of these cells are released into the bloodstream and spread around the body, interfering with the body’s production of healthy blood cells.

About the SABRINA study (BO22334)

SABRINA is a two-stage international phase III trial designed to investigate the pharmacokinetics, efficacy and safety of SC versus IV administration of MabThera in FL patients receiving induction and maintenance therapy. In the first stage (dose-confirmation) with pharmacokinetics (Ctrough) as primary endpoint, treatment-naïve patients with follicular lymphoma, a common type of NHL, were randomised to receive 375 mg/m2 MabThera administered intravenously or a fixed dose of 1,400 mg of MabThera via subcutaneous delivery, both given in combination with either CHOP or CVP chemotherapy. Patients who achieved a complete or partial response after 8 treatment cycles continued MabThera maintenance therapy as per their initial randomisation with either SC or IV administration. The SABRINA study met its primary endpoint of demonstrating non-inferior MabThera serum concentration after SC injection compared with IV infusion. No new medically relevant safety signals were observed and administration related reactions were mostly of mild to moderate severity. Exploratory efficacy analysis from SABRINA was also performed to demonstrate that a switch from IV to SC administration can be achieved without compromising MabThera’s anti-lymphoma efficacy: Similar overall response rates (ORR) [84.4% IV and 90.5% SC] and complete response (CR) rates [29.7% IV and 46% SC] support the conclusion of comparable efficacy. In the second stage with efficacy as the primary endpoint, additional patients will be randomized to either SC or IV administration of MabThera.

About Roche in hematology

For more than 20 years, Roche has been developing medicines that redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with cancers of the blood.

In addition to MabThera and Gazyva, Roche’s pipeline of potential hematology medicines includes two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22 [RG7593]), a small molecule antagonist of MDM2 (RG7112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (RG7601/GDC-0199/ABT-199).

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, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

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1) Globocan (2008) Table by cancers. Worldwide incidence of cancers in males and females. (URL accessed 18.19.13).
2) Globocan (2008) Cancer Incidence and Mortality Worldwide. World, non-Hodgkin lymphoma, 2010. (URL accessed 18.09.13).