Chapter 12. Rituximab: Clinical Development of the First Therapeutic Antibody for Cancer

  1. Dr. Oliver Kayser,
  2. Prof. Dr. Rainer H. Müller
  1. Dr. Antonio J. Grillo-López

Published Online: 28 JAN 2005

DOI: 10.1002/3527602410.ch12

Book Title

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Additional Information

How to Cite

Grillo-López, A. J. (2005) Rituximab: Clinical Development of the First Therapeutic Antibody for Cancer, in Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications (eds O. Kayser and R. H. Müller), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, FRG. doi: 10.1002/3527602410.ch12

Editor Information

  1. Free University Berlin, Institute of Pharmacy, Pharmaceutical Technology, Biopharmacy & Biotechnology, Kelchstr. 31, 12169 Berlin, Germany

Author Information

  1. Neoplastic and Autoimmune Diseases, Research Institute, P. O. Box 3797, Rancho Santa Fe, CA 92067, USA

Publication History

  1. Published Online: 28 JAN 2005
  2. Published Print: 28 JAN 2004

ISBN Information

Print ISBN: 9783527305544

Online ISBN: 9783527602414

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CHAPTER TOOLS

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Keywords:

  • pharmaceutical biotechnology;
  • rituximab;
  • clinical development;
  • therapeutic antibody for cancer;
  • repeated treatment;
  • combinations with chemotherapy;
  • combinations with biologicals;
  • interferon;
  • combinations with radioimmunotherapy;
  • Zevalin

Summary

  • Introduction

  • Clinical Development and Regulatory Approvals

    • Clinical Development

    • The Clinical Development Plan

    • Clinical Trials Methodology

    • Response Criteria

    • The Medical Research and Regulatory Affairs Staff

    • Phase I and I/II Clinical Trials

    • Phase II and III Clinical Trials

      • Rituximab in Bulky Disease

      • Optimizing the Dose and Schedule

      • Repeated Treatment – as Maintenance or Following Disease Progression

      • Combinations with Chemotherapy: The R + CHOP Combination

      • Combinations with Biologicals: Rituximab + Interferon

      • Combinations with Radioimmunotherapy: Rituximab + Zevalin

    • Regulatory Dossiers, Review, and Approvals

  • Rituximab: Other Indications/Applications

  • Conclusions: Achievements, Current Role, and Future Applications of Rituximab

  • Acknowledgments

  • References

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