ARZERRA (ofatumumab)
ARZERRA is indicated for the treatment of Previously untreated chronic lymphocytic leukemia in combination with chlorambucil for patients for whom fludarabine-based therapy is considered inappropriate; Relapsed chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide; Extended treatment of recurrent or progressive chronic lymphocytic leukemia in patients with complete or partial response after at least two lines of therapy; Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
How ARZERRA Works
Ofatumumab targets the CD20 molecule expressed on the surface of normal and malignant B lymphocytes. The antibody binds to the extracellular loops of CD20 and remains on the cell surface without being internalized or shed. This binding allows the drug to mediate immune effector functions, resulting in the lysis of B cells. Suggested mechanisms for this cell death include complement-dependent cytotoxicity and antibody-dependent, cell-mediated cytotoxicity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-10-26
- Patent Cliff
- 2023
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ARZERRA Approval History
What ARZERRA Treats
4 indicationsARZERRA is approved for 4 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Previously untreated chronic lymphocytic leukemia in combination with chlorambucil for patients for whom fludarabine-based therapy is considered inappropriate
- Relapsed chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide
- Extended treatment of recurrent or progressive chronic lymphocytic leukemia in patients with complete or partial response after at least two lines of therapy
- Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab
ARZERRA Boxed Warning
HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA ® , in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnings and Precautions (5.2)] . Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautio...
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA ® , in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnings and Precautions (5.2)] . Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautions (5.4)] . WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ( 5.4 )
ARZERRA Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
ARZERRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ARZERRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ARZERRA treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
93 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03650114 ALITHIOS | COMB157G2399 2023-507906-15 | Ph 3 | active not recruiting | Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS |
| NCT04926818 NEOS | CBAF312D2301 | Ph 3 | active not recruiting | Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis |
| NCT04353492 ARTIOS results posted | COMB157G23101 2019-001341-40 | Ph 3 | completed | An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab |
| NCT05090371 SOSTOS | COMB157GUS09 | Ph 4 | active not recruiting | A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation |
| NCT02135133 results posted | 13-309 | Ph 2 | completed | A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL |
| NCT04788615 STHENOS | COMB157G3301 2020-004505-32 | Ph 3 | completed | Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS |
| NCT05084638 AGNOS results posted | COMB157GUS10 | Ph 4 | completed | Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls. |
| NCT03136146 | 2016-0211 NCI-2018-01198, 2016-0211 | Ph 2 | recruiting | Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia |
| NCT05504694 | K202206-13 | Ph 1, Ph 2 | recruiting | Ofatumumab in AQP4-IgG Seropositive NMOSD |
| NCT04510220 results posted | 2020P002078 | Ph 3 | completed | 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis |
| NCT05199571 results posted | COMB157G2402 | Ph 4 | completed | Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China |
| NCT04486716 OLIKOS results posted | COMB157GUS07 111,116 | Ph 3 | completed | A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis |
| NCT01496976 results posted | MCC-16622 COMB157BUS21T, RV-CLL-PI-0560 | Ph 2 | completed | Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL |
| NCT01286272 results posted | NCI-2011-02625 NCI-2011-02625, CALGB-50904 | Ph 2 | completed | Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma |
| NCT02877303 | 2014-0845 NCI-2017-00596, 2014-0845 | Ph 2 | recruiting | Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT01258933 results posted | 2010-0266 NCI-2011-00274 | Ph 2 | terminated | Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy |
| NCT06867991 RADIA | RADIA-2024-11 | Ph 3 | recruiting | Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis |
| NCT01361711 results posted | NU 10H06 NCI-2011-00514, STU00044115 | Ph 2 | active not recruiting | Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia |
| NCT04878211 results posted | COMB157GUS16 | Ph 4 | terminated | A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab |
| NCT04869358 KYRIOS results posted | COMB157GDE01 | Ph 4 | completed | Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab |
| NCT01458366 results posted | 11D.404 2011-61, JT 2211 | Ph 1, Ph 2 | completed | Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide |
| NCT01352312 | 11P.166 2011-23, OFT114197 | Ph 1 | terminated | Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma |
| NCT04667117 results posted | COMB157GUS12 | Ph 4 | completed | A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab |
| NCT01243190 results posted | 2010-0241 NCI-2011-00745 | Ph 2 | completed | Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT03488225 results posted | 2015-0922 NCI-2018-00760, 2015-0922 | Ph 2 | terminated | Combination Chemotherapy and Inotuzumab Ozogamicin in Treating Patients With B Acute Lymphoblastic Leukemia |
| NCT02199184 results posted | 2014-0123 NCI-2014-01707, 2014-0123 | Ph 2 | completed | Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refractory Acute Lymphoblastic Leukemia |
| NCT01527149 results posted | I 201611 NCI-2011-03562, I 201611 | Ph 2 | completed | Ofatumumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone Alternating With Ofatumumab in Combination With Cytarabine and Methotrexate in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma |
| NCT01145209 results posted | 100141 10-H-0141 | Ph 2 | completed | Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL |
| NCT01060384 results posted | 0514-09-FB | Ph 1, Ph 2 | completed | Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma |
| NCT02049515 results posted | IPI-145-12 2013-003639-31 | Ph 3 | completed | A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07 |
| NCT02004522 results posted | IPI-145-07 2013-002405-61 | Ph 3 | completed | A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) |
| NCT01465334 results posted | 11-304 NCCN Protocol Number: NCCN-001, GSK Protocol Number: OFT115580 | Ph 2 | terminated | Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL |
| NCT01680965 results posted | MCC-17071 | Ph 1, Ph 2 | completed | Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease |
| NCT01555541 results posted | 112525 NCI-2012-00863 | Ph 2 | completed | Intensive Consolidation and Stem Cell Mobilization Therapy Followed by Autologous Stem Cell Transplantation in High-risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT02710643 FIL_MIRO | FIL_MIRO | Ph 2 | completed | "MIRO" Molecularly Oriented Immuno-radio-therapy |
| NCT01455051 | GETH-CLL4 2010-024467-40 | Ph 2 | completed | Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation |
| NCT03249714 results posted | COMB157G1301 | Ph 2 | completed | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab |
| NCT01481272 PLRG8 | PLRG8 (OMB114361) 2010-023568-42 | Ph 2 | completed | Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients |
| NCT01190449 results posted | CALGB-50901 CALGB-50901, GSK-CALGB-50901 | Ph 2 | completed | Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma |
| NCT01444716 results posted | 2011-0520 NCI-2018-01841, 2011-0520 | Ph 2 | completed | Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia |
| NCT01613300 | GELTAMO-O-CRT-2011 2011-004729-29 | Ph 2 | completed | Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients |
| NCT01363128 results posted | 2010-0708 NCI-2011-01061, 2010-0708 | Ph 2 | completed | Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT01497496 results posted | MCC-16631 COMB157AUS08T, RV-CLL-PI-0560 | Ph 2 | completed | Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) |
| NCT01088048 results posted | 101-07 | Ph 1 | completed | Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia |
| NCT01762202 CLL0911 | CLL0911 2011-005329-27 | Ph 2 | completed | Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia. |
| NCT02394119 | OFA2 | Ph 2 | completed | Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor Dependent Idiopathic Nephrotic Syndrome |
| NCT02394106 | OFA1 | Ph 2 | terminated | Ofatumumab in Children With Drug Resistant Idiopathic Nephrotic Syndrome |
| NCT01329900 results posted | 2009-0796 NCI-2011-01068 | Ph 2 | completed | Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas |
| NCT02689141 | CLL2-BIO 2014-000590-39 | Ph 2 | completed | Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO) |
| NCT01077518 A+B results posted | 110918 2008-004177-17, COMB157E2301 | Ph 3 | terminated | Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy |
Showing 50 of 93 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARZERRA FDA Label Details
Indications & Usage
FDA Label (PDF)ARZERRA is indicated for the treatment of Previously untreated chronic lymphocytic leukemia in combination with chlorambucil for patients for whom fludarabine-based therapy is considered inappropriate; Relapsed chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide; Extended treatment of recurrent or progressive chronic lymphocytic leukemia in patients with complete or partial response after at least two lines of therapy; Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA ® , in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnin...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment