Rituximab (Mabthera(R) Rituxan(R)) is a genetically engineered chimeric mur
ine/human monoclonal antibody directed against the CD20 antigen found on th
e surface of normal and malignant B lymphocytes; it has recently been licen
sed in the United States and Europe as a novel antibody therapy for patient
s with relapsed or refractory low-grade or follicular, CD20 positive, B-cel
l non-Hodgkin's lymphoma (NHL). Preclinical studies have shown that rituxim
ab specifically recognizes the CD20 antigen, can induce human effector mech
anisms in vitro, and effectively depletes B cells in cynomolgus monkeys wit
h limited toxicity. Previous clinical studies have demonstrated that 4 infu
sions of 375 mg/m(2) rituximab given over a 22-day period in patients with
low-grade NHL is effective, with an overall response rate of 50%. Adverse e
vents associated with treatment are primarily mild and are most frequent wi
th the first infusion, decreasing with subsequent infusions. B cells are ef
fectively depleted during treatment: Levels return to normal ranges between
9 and 12 months post-treatment. Immunoglobulin levels of IgM, IgG, and IgA
remain within the normal range. A human anti-chimeric antibody response ha
s been detected in only less than 1% of patients treated and has not interf
ered with treatment. Rituximab offers a novel, effective, well-tolerated al
ternative treatment for NHL compared with existing therapies. The clinic al
success of rituximab reinforces the promising potential of a nti body ther
apy.