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Rituximab

Rituximab was the first antibody ever approved for cancer (1997). It made chemoimmunotherapy the CLL standard for a decade, and biosimilars keep it cheap and everywhere.

Approved in follicular lymphoma (1997), DLBCL (2006, R-CHOP), CLL (2010, with fludarabine-cyclophosphamide: FCR, the first regimen to show OS benefit in CLL). Superseded in CLL by targeted agents (CLL13, CLL14, ELEVATE-TN) but still used with venetoclax in relapse (MURANO: venetoclax-rituximab 24 months) and in resource-limited settings. Biosimilars (Truxima, Ruxience, Riabni) since 2018.

Schematic of the modality · Monoclonal antibody (anti-CD20, chimeric) · not a molecule; see the Monoclonal antibodies page
Mechanism, step by step
auto-advancing · hover to pause

1.Binds CD20 and clusters it into lipid rafts

Modality
Monoclonal antibody (anti-CD20, chimeric)
Mechanism
Chimeric type I anti-CD20 IgG1: CDC, ADCC, and modest direct signalling.
Brand / code
Rituxan / MabThera (and biosimilars)
Dosing & schedule
Route
IV or subcutaneous (Rituxan Hycela)
Schedule
CLL: 375 mg/m² cycle 1 then 500 mg/m² cycles 2-6 with chemotherapy or venetoclax
Monitoring
Infusion reactions, HBV reactivation (boxed), PML (boxed), late-onset neutropenia

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9312 for Rituxan; biosimilars Truxima, Ruxience and Riabni have their own codes. Rituxan Hycela (subcutaneous) is Part B.

Commercial insurance
step therapy common

Preferred rituximab biosimilar required by most commercial medical-benefit programmes; prior authorisation confirms CD20-positive disease.

Assistance programmes

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · FDA: Biosimilars. Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA65 · 2003SMC: accepted
Appraised for
Aggressive (diffuse large B-cell) non-Hodgkin lymphoma with CHOP
Notes
Follicular lymphoma (TA110, TA137, TA226), CLL (TA174, TA193). Biosimilars since 2017 dominate NHS use. Subcutaneous form available.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA65 · SMC advice: rituximab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US1997Relapsed follicular lymphoma; first antibody approved for cancer
US2010CLL with fludarabine and cyclophosphamide

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Infusion-related reactions (first infusion)
Historic lymphoma data; lower with premedication
77%
Hepatitis B reactivation
Boxed warning; screen all patients
Late-onset neutropenia
8%

Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
2029 studies12 recruiting80 Phase 223 Phase 3
Search “Rituximab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Rituximab
intervention: Rituximab
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend1,702 papers in the last 12 months+11% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Rituximab" OR ABSTRACT:"Rituximab" OR TITLE:"Rituxan" OR ABSTRACT:"Rituxan" OR TITLE:"MabThera" OR ABSTRACT:"MabThera" OR TITLE:"and biosimilars" OR ABSTRACT:"and biosimilars") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Rituximab, not a curated reading list.

Connected

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