Rituximab
- Generic Name
- Rituximab
- Brand Names
- MabThera, Riabni, Rituxan, Rituxan Hycela, Ruxience, Truxima, Blitzima, Rixathon, Riximyo
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 174722-31-7
- Unique Ingredient Identifier
- 4F4X42SYQ6
- Background
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...
- Indication
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 pat...
- Associated Conditions
- Active, Moderate to Severe Rheumatoid Arthritis, Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Non-Hodgkin's Lymphoma, Granulomatosis With Polyangiitis, Microscopic Polyangiitis (MPA), Advanced Burkitt Lymphoma (BL), Advanced Burkitt-like lymphoma, Advanced Diffuse Large B-Cell Lymphoma (DLBCL), Advanced Mature B-cell type acute leukaemia, Moderate Pemphigus Vulgaris (PV), Non-progressive Low Grade Non-Hodgkin's Lymphoma (NHL), Refractory Low Grade Non-Hodgkin's Lymphoma (NHL), Refractory follicular B-cell non-Hodgkin's lymphoma, Relapsed Low Grade Non-Hodgkin's Lymphoma (NHL), Relapsed follicular B-cell non-Hodgkin's lymphoma, Severe Pemphigus Vulgaris (PV)
- Associated Therapies
- -
Five-year results confirm Roche's Polivy combination
Five-year follow-up of POLARIX study shows positive trend in overall survival for Polivy + R-CHP in first-line DLBCL, fewer subsequent treatments needed, and maintained benefits in progression-free and disease-free survival.
FDA Sets Goal Date for Lymphoma Drug Columvi
Genentech's sBLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) has been accepted by the FDA, with a decision expected by July 20, 2025. The sBLA is based on the phase 3 STARGLO study, showing a 41% reduction in death risk and 63% reduction in disease worsening risk with Columvi plus GemOx compared to Rituxan plus GemOx. Common adverse effects include cytokine release syndrome, managed with a step-up dosing schedule.
FDA Accepts Roche's Supplemental Biologics License Application of Columvi for Relapsed
The FDA accepted Roche's sBLA for Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in patients ineligible for autologous stem cell transplant. The Phase III STARGLO trial showed a statistically significant and clinically meaningful overall survival (OS) improvement with Columvi-GemOx compared to Rituxan-GemOx, making Columvi the first CD20xCD3 bispecific antibody to demonstrate a survival benefit in DLBCL in a randomized Phase III trial.
Microbial Fermentation Technology Market to Reach USD 53.25
The microbial fermentation technology market was valued at USD 31.97 Billion in 2023 and is projected to reach USD 53.25 Billion by 2032, growing at a CAGR of 5.91%. This growth is driven by advancements in biotechnology, demand for sustainable production, and investments in alternative protein companies. Key segments include antibiotics, monoclonal antibodies, and CMOs & CDMOs, with Asia Pacific leading the market and North America poised for fast growth.
FDA Accepts Supplemental Biologics License Application for Genentech's Columvi
Genentech's sBLA for Columvi plus GemOx in R/R DLBCL accepted by FDA, based on Phase III STARGLO study showing significant OS improvement. Expected decision by July 20, 2025.
Related Clinical Trials:
Press Releases | Wednesday, Dec 4, 2024
FDA accepts Genentech's sBLA for Columvi plus chemotherapy for relapsed or refractory diffuse large B-cell lymphoma, based on Phase III STARGLO study data showing significant overall survival improvement. Expected approval decision by July 20, 2025.
Related Clinical Trials:
First CD20xCD3 Antibody Shows Survival Benefits in Phase III Lymphoma Trial
FDA accepts Roche's sBLA for Columvi + GemOx for relapsed/refractory DLBCL, based on phase III STARGLO study showing significant OS improvement. Decision expected by July 20, 2025.
Related Clinical Trials:
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
US originator biologic companies may increase rebates by up to 89% and reduce net prices by up to 51% to counter biosimilar competition, according to a study in *Expert Opinion on Biological Therapy*. The study highlights the impact of biosimilar entries on pricing, with significant net price reductions and rebate increases across biologics like trastuzumab, pegfilgrastim, infliximab, and rituximab. The authors suggest that promoting 1-2 biosimilars per market may be more effective for cost savings than supporting multiple biosimilars in fewer markets.
Zenyaku Kogyo receives Japanese approval for anti-CD20 monoclonal antibody, Rituxan to treat chronic idiopathic thrombocytopenic purpura (ITP) in children
Zenyaku Kogyo and Chugai Pharmaceutical received MHLW approval for Rituxan (rituximab) for chronic idiopathic thrombocytopenic purpura (ITP) in children, expanding its use beyond adults. This follows a request by the Japanese Society of Paediatric Haematology/Oncology and a public knowledge-based application process. Rituxan, an anti-CD20 monoclonal antibody, targets B cells implicated in ITP pathogenesis, offering a treatment option for pediatric ITP patients resistant to primary therapies.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2024. All Rights Reserved by MedPath