Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences , . It was originally approved by the U.S. FDA in 1997 as a single agent to treat patients with B-cell Non-Hodgkin's Lymphoma (NHL) , however, has now been approved for a variety of conditions . On November 28, 2018, the US FDA approved Truxima, the first biosimilar to Rituxan (Rituximab) .
Rituximab is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s Lymphoma (NHL) as a single agent. Also, it is indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Additionally, rituximab is indicated for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; and previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
Rituximab, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). In combination with methotrexate, rituximab is indicated for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Additionally, rituximab, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA).
RITUXAN (rituximab injection for intravenous use) is indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy; as well as the treatment of adult patients with moderate to severe pemphigus vulgaris. These indications for RITUXAN are not included in the labels of rituximab biosimilar products (rituximab-arrx, rituximab-abbs, rituximab-pvvr). The combination product RITUXAN HYCELA (rituximab and hyaluronidase human injection, for subcutaneous use) is not indicated for the treatment of non-malignant conditions.
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Stony Brook University, Stony Brook, New York, United States
OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Fundeni Clinical Institute, Bucharest, Romania
Tianjin Cancer Hospital /ID# 228135, Tianjin, Tianjin, China
Peking University Third Hospital /ID# 228138, Beijing, Beijing, China
The Fifth Medical Center of PLA General Hospital /ID# 230520, Beijing, Beijing, China
First affiliation hospital of nanjing medical university, Nanjing, Jiangsu, China
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjin, Jiangsu, China
Ironwood cancer and research center, Chandler, Arizona, United States
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics, Duarte, California, United States
Kaiser Permanente - Irvine, Irvine, California, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Hospital Español Auxilio Mutuo, San Juan, Puerto Rico
New York Cancer & Blood Specialists - New Hyde Park, Babylon, New York, United States
Grampians Health ( Site 1802), Ballarat, Victoria, Australia
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029), Luoyang, Henan, China
CIMCA ( Site 2501), San Jose, Costa Rica
Ucsf Fresno University of California San Francisco Fresno, Fresno, California, United States
Kaiser Permanente Southern California, Irvine, California, United States
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
First Pavlov State Medical University of St. Petersburg, Saint Petersburg, Russian Federation
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
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