TY - JOUR
T1 - Development trends for human monoclonal antibody therapeutics
AU - Nelson, Aaron L.
AU - Dhimolea, Eugen
AU - Reichert, Janice M.
PY - 2010/10
Y1 - 2010/10
N2 - 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.
AB - 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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U2 - 10.1038/nrd3229
DO - 10.1038/nrd3229
M3 - Review article
C2 - 20811384
AN - SCOPUS:77957361348
SN - 1474-1776
VL - 9
SP - 767
EP - 774
JO - Nature Reviews Drug Discovery
JF - Nature Reviews Drug Discovery
IS - 10
ER -