RITUXAN Indications

First-line and Previously Treated CLL in combination with FC

RITUXAN^® (Rituximab) is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.

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• In first-line CLL, RITUXAN+FC provided an 8.3-month improvement in median progression-free survival (PFS) vs FC alone¹
• In previously treated* CLL, RITUXAN+FC provided a 5.0-month improvement in median PFS vs FC alone¹
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Safety summary:

• In the CLL8 trial of first-line CLL, Grade 3 or 4 adverse reactions that occurred more frequently (≥2%) in patients treated with R-FC vs FC were neutropenia (30% vs 19%), febrile neutropenia (9% vs 6%), leukopenia (23% vs 12%), and pancytopenia (3% vs 1%)¹
• In the REACH trial of patients with previously treated CLL, Grade 3 or 4 adverse reactions that occurred more frequently (≥2%) in patients treated with R-FC vs FC were neutropenia (49% vs 44%), febrile neutropenia (15% vs 12%), thrombocytopenia (11% vs 9%), hypotension (2% vs 0%), and hepatitis B (2% vs <1%)¹

Treatment Considerations

The CLL8 and REACH trials were not designed or powered to detect a significant difference in PFS by age category. However, exploratory analyses defined by age suggest no observed benefit with the addition of RITUXAN to FC chemotherapy in previously untreated CLL patients 70 years of age or older and in previously treated CLL patients 65 years of age or older.¹

First-line DLBCL with CHOP

For previously untreated diffuse large B-cell, CD20-positive Non-Hodgkin's Lymphoma (DLBCL) in combination with CHOP or other anthracycline-based chemotherapy regimens

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• 7-year overall survival (OS) was 53% for 8 cycles of R-CHOP vs 36% for CHOP alone (p=0.0004)³
• 5-year OS was 58% for 8 cycles of R-CHOP vs 46% for CHOP alone¹
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Safety summary:

• In studies of elderly patients with DLBCL, the following adverse reactions, regardless of severity, were reported more frequently (≥5%) in patients ≥60 years of age receiving R-CHOP as compared with CHOP alone: pyrexia (56% vs 46%), lung disorder (31% vs 24%), cardiac disorder (29% vs 21%), and chills (13% vs 4%). Detailed safety data collection in these trials was primarily limited to Grade 3 and 4 adverse reactions and serious reactions. In one of the studies of elderly patients, GELA LNH 98-5, a review of cardiac toxicity determined that supraventricular arrhythmias or tachycardia accounted for most of the difference in cardiac disorders (4.5% for R-CHOP vs 1.0% for CHOP)¹
• The following Grade 3 or 4 adverse reactions occurred more frequently among patients in the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs 7%) and lung disorder (6% vs 3%). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving R-CHOP were viral infection (GELA LNH 98-5 trial), neutropenia (GELA LNH 98-5 and MInT trials), and anemia (MInT trial)¹

Learn more about first-line DLBCL with CHOP.

First-line Follicular NHL with CVP

For previously untreated follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) in combination with CVP chemotherapy

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• 127% improvement in median PFS: 2.83 years R-CVP vs 1.25 years CVP (4.4-year follow-up p<0.0001)⁴
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Safety summary:

• Patients in the R-CVP arm had higher incidences of infusional toxicity and of neutropenia as compared to those in the CVP arm. The following adverse reactions occurred more frequently (≥5%) in patients receiving R-CVP compared to CVP alone: rash (17% vs 5%), cough (15% vs 6%), flushing (14% vs 3%), rigors (10% vs 2%), pruritus (10% vs 1%), neutropenia (8% vs 3%), and chest tightness (7% vs 1%)¹

Learn more about first-line follicular NHL with CVP.

First-line Low-grade NHL following CVP

For non-progressing (including stable disease), low-grade, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL), as a single agent, after first-line CVP chemotherapy

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• 104% improvement in overall PFS¹*
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*Based on the hazard ratio of 0.49 found in the prescribing information. Improvement in overall PFS was calculated using the formula (1-HR)/HR.

Safety summary:

• The following common adverse reactions were reported more frequently (≥5%) in patients receiving RITUXAN following CVP compared with those who received no further therapy: fatigue (39% vs 14%), anemia (35% vs 20%), peripheral sensory neuropathy (30% vs 18%), infections (19% vs 9%), pulmonary toxicity (18% vs 10%), hepatobiliary toxicity (17% vs 7%), rash and/or pruritus (17% vs 5%), arthralgia (12% vs 3%), and weight gain (11% vs 4%)¹
• Neutropenia was the only Grade 3 or 4 adverse reaction that occurred more frequently (≥2%) in the RITUXAN arm compared with those who received no further therapy (4% vs 1%)¹

Learn more about first-line low-grade NHL following CVP.

Relapsed or Refactory, Low-grade or Follicular NHL

For relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) as a single agent: Retreatment, Weekly x4, Weekly x8, Bulky disease

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• RITUXAN demonstrated durable responses in heavily pretreated patients⁵
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Safety summary:

• In RITUXAN clinical trials of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL, the most common Grade 3 or 4 adverse reactions (>1%) observed in patients receiving single-agent RITUXAN (N=356) were lymphopenia (40%), neutropenia (6%), leukopenia (4%), infection (4%), anemia (3%), chills (3%), and thrombocytopenia (2%)¹

Learn more about relapsed or refractory, low-grade or follicular NHL.

View Indication and Safety Information
Redefining Outcomes in NHL Therapy