3月28日，罗氏表示，欧盟委员会批准其利妥昔单抗（MabThera）皮下注射剂药物，用于滤泡型淋巴瘤及弥漫性大B细胞淋巴瘤患者治疗。罗氏首席医疗官Sandra Horning称，“我们认为，与大约2.5小时输液时间的利妥昔单抗静脉注射剂相比，只需五分钟给药时间的皮下注射剂药物会明显改善患者的治疗。”
罗氏指出，这项批准决定主要基于关键的SABRINA研究数据，此前，欧洲药品管理局人用医药产品委员于1月份给予了这款产品积极的推荐意见。罗氏补充说，该公司计划在2014年向大多数欧洲市场推出这款皮下注射剂药物。
利妥昔单抗在美国、日本及加拿大以美罗华为商品名上市，这款药物最初于1997年被FDA批准用于非霍奇金淋巴瘤(NHL)治疗，1998年在欧洲获得批准。该药物也被批准用于几种血液癌症治疗，特别是某些类型的NHL及用于慢性淋巴细胞白血病治疗。这款产品在美国由罗氏基因泰克及百健艾迪上市销售，在世界其它市场（日本除外）由罗氏上市销售，在日本由罗氏与中外制药及ZenyakuKogyo制药共同销售。
这次利妥昔单抗皮下注射剂药物获批之前，罗氏皮下注射剂型的曲妥珠单抗（赫赛汀）去年已在欧洲获批用于HER2阳性乳腺癌治疗。
Roche's new time-saving subcutaneous formulation of MabThera approved in Europe for the treatment of common forms of non-Hodgkin Lymphoma
MabThera SC offers a faster treatment experience for patients while saving valuable time for health systems
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved a new subcutaneous (SC) formulation of MabThera (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Following the approval of Herceptin SC in September 2013, this is the second European approval for a novel subcutaneous formulation of one of Roche’s oncology products.
“As part of our mission to improve people’s lives, we are pleased that MabThera SC has been approved for patients with common forms of non-Hodgkin lymphoma”, said Sandra Horning, M.D., Chief Medical Officer and Head, Global Product Development. “We believe that the faster five minute administration will significantly improve the treatment experience for patients and providers compared to the approximate 2.5 hour infusion time for intravenous MabThera.”
The European approval was based primarily on data from the pivotal SABRINA study, which was recently published in The Lancet Oncologyi.
Roche expects to begin launching MabThera SC in a number of European markets throughout 2014.
ab0ut 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 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.
MabThera (Rituxan in the United States, Japan and Canada), discovered by Biogen Idec, first received FDA approval for the treatment of relapsed indolent non-Hodgkin Lymphoma (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, and has since been used to treat more than 2.7 million people with specific blood cancers. 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). 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.
ab0ut non-Hodgkin lymphoma
There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL).
NHL represents approximately 85% of all lymphoma diagnosedii and was responsible for approximately 200,000 annual deaths worldwide in 2012iii.
Lymphomas are a cancer of the lymphatic system (composed of lymph vessels, lymph nodes and organs) which helps to keep the bodily fluid levels balanced and to defend the body against invasion by disease. 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.
ab0ut 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 an anti-CD79b antibody drug conjugate (RG7596/polatuzumab vedotin), a small molecule antagonist of MDM2 (RG7112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (RG7601/GDC-0199/ABT-199).
ab0ut 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, immunology, infectious diseases, ophthalmology 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 personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making imp0rtant contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 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 www.roche.com.
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