Development trends for human monoclonal antibody therapeutics

Aaron L. Nelson, Eugen Dhimolea, Janice M. Reichert

Research output: Contribution to journalReview articlepeer-review

789 Scopus citations

Abstract

Fully human monoclonal antibodies (mAbs) are a promising and rapidly growing category of targeted therapeutic agents. The first such agents were developed during the 1980s, but none achieved clinical or commercial success. Advances in technology to generate the molecules for study- in particular, transgenic mice and yeast or phage display- renewed interest in the development of human mAbs during the 1990s. In 2002, adalimumab became the first human mAb to be approved by the US Food and Drug Administration (FDA). Since then, an additional six human mAbs have received FDA approval: panitumumab, golimumab, canakinumab, ustekinumab, ofatumumab and denosumab. In addition, 3 candidates (raxibacumab, belimumab and ipilimumab) are currently under review by the FDA, 7 are in Phase III studies and 81 are in either Phase I or II studies. Here, we analyse data on 147 human mAbs that have entered clinical study to highlight trends in their development and approval, which may help inform future studies of this class of therapeutic agents.

Original languageEnglish (US)
Pages (from-to)767-774
Number of pages8
JournalNature Reviews Drug Discovery
Volume9
Issue number10
DOIs
StatePublished - Oct 2010
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology
  • Drug Discovery

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