Development trends for human monoclonal antibody therapeutics

AL Nelson, E Dhimolea, JM Reichert - Nature reviews drug discovery, 2010 - nature.com
AL Nelson, E Dhimolea, JM Reichert
Nature reviews drug discovery, 2010nature.com
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 …
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.
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