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Rituximab: ongoing and future clinical development.
Antonio J Grillo-López1, Eric Hedrick, Michelle Rashford
1Antonio J. Grillo-López, Consultant Clinical Research and Regulatory Strategy, Genentech, Inc, South San Francisco, CA 94080-4990, USA.
Seminars in Oncology
|February 14, 2002
Summary
Rituximab, the first monoclonal antibody approved for cancer, has been used in over 125,000 patients. Ongoing research explores its use in combination therapies and for various malignant and non-neoplastic conditions.
Area of Science:
- Oncology
- Immunology
- Pharmacology
Background:
- Monoclonal antibodies are established therapeutic agents.
- Rituximab was the first monoclonal antibody approved by the US FDA for a cancer indication in 1997.
- Rituximab is approved for CD20-positive B-cell non-Hodgkin's lymphoma in the US and Europe.
Purpose of the Study:
- To review the clinical applications of rituximab.
- To discuss ongoing and future clinical trials involving rituximab.
- To highlight areas for further research and development of rituximab.
Main Methods:
- Review of clinical research and trial data over 9 years.
- Analysis of regulatory approvals and physician communications.
- Synthesis of information on current and potential therapeutic uses.
Main Results:
- Rituximab has been approved in 56 countries and used in over 125,000 patients in the US.
- Significant clinical research has expanded the understanding of rituximab's applications.
- The drug has spurred interest in other monoclonal antibody therapies.
Conclusions:
- Rituximab has demonstrated significant therapeutic value in non-Hodgkin's lymphoma.
- Further research is needed for combination therapies, multimodality regimens, and non-lymphoma applications.
- The potential of monoclonal antibodies like rituximab in oncology and other fields is substantial.