The FDA has approved lenalidomide (Revlimid®, Celgene Corporation) in combination with rituximab (R2) for adults previously treated for follicular lymphoma (FL) or marginal zone lymphoma (MZL). This is the first combination-treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not involve chemotherapy.
Indolent lymphomas, which account for approximately 40% of all NHL cases, are slow-growing forms of the disease. Patients can often be asymptomatic or have fewer symptoms upon diagnosis.
Although chemotherapy is a standard of care for indolent forms of NHL, most patients either relapse or become refractory to their current treatment. Immune dysfunction is a defining aspect of FL and MZL; when it occurs, the immune system’s lymphocytes fail to detect or target cancerous cells.
The R2 approval is based largely on results from the randomized, double-blind, phase 3 AUGMENT study, which showed the combination significantly improved median progression-free survival (PFS) versus rituximab monotherapy. The median PFS was 39.4 months for patients treated with R2 and 14.1 months for patients treated with rituximab-placebo.
In participants with FL/MHL, adverse reactions included neutropenia, diarrhea, constipation, cough, fatigue, rash, pyrexia, leukopenia, pruritus, upper respiratory tract infections, abdominal pain, anemia, headache, and thrombocytopenia.
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