Title: Rituximab The First Monoclonal Antibody Approved for the Treatment of Lymphoma
Volume: 1
Issue: 1
Author(s): A. J. Grillo-Lopez, C. A. White, B. K. Dallaire, C. L. Varns, C. D. Shen, A. Wei, J. E. Leonard, A. McClure, R. Weaver, S. Cairelli and J. Rosenberg
Affiliation:
Keywords:
Rituximab, Monoclonal Antibody, Lymphoma, B cell, CD20 positive
Abstract: Rituximab, a genetically engineered monoclonal chimeric antibody, targets the CD20 antigen expressed on B cells. It was approved by the US Food and Drug Administration on November 26, 1997, for the indication of relapsed or refractory, CD20-positive, B-cell, low-grade or follicular non-Hodgkins lymphoma (LG/F NHL), and by the European Agency for the Evaluation of Medicinal Products on June 2, 1998, for therapy of patients with Stage III/IV, follicular, chemoresistant or relapsed NHL. Eight Phase II or III clinical trials in LG/F NHL patients have been completed five single-agent studies and three combination studies. Rituximab has a favorable safety profile most adverse events (AEs) are Grade 1 or 2, and the frequency of AEs decrease with subsequent infusions. AEs in the combination studies are consistent with those seen with individual agents. For evaluable patients in the single-agent studies, overall response rates (ORR) ranged from 40percent to 60percent, median duration of response (DR) r anged from 5.9 to 15.0+ months, and median time to progression (TTP) ranged from 8.1 to 19.4+ months. For evaluable patients in the combination studies, the ORR ranged from 45percent to 100percent, median DR ranged from 11.7+ to 39.1+ months, and median TTP ranged from 12.9+ to 40.5+ months. Studies in intermediate- and high-grade NHL are ongoing. Long-term development plans include evaluating the safety and efficacy of rituximab in various types of lymphoma and in combination with other lymphoma regimens. Future studies may explore ways to increase rituximab efficacy by upregulating CD20 or increasing effector function with different cytokines.
