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MAbs. 2013 Jul-Aug;5(4):513-7. doi: 10.4161/mabs.24990. Epub 2013 May 9.

Antibodies to watch in 2013: Mid-year update.

Abstract

The transitions of antibody therapeutics to late-stage clinical development, regulatory review and the market are proceeding at a rapid pace in 2013. Since late 2012, two monoclonal antibody (mAb) therapeutics (itolizumab, trastuzumab emtansine) received their first approvals, first marketing applications for three mAbs (vedolizumab, ramucirumab, obinutuzumab) were submitted to regulatory agencies, and five mAbs (brodalumab, MABp1, moxetumomab pasudotox, tildrakizumab, rilotumumab) entered their first Phase 3 studies. The current total of commercially-sponsored antibody therapeutics undergoing evaluation in late-stage studies is 30. Recently announced study results for farletuzumab, naptumomab estafenatox, and tabalumab indicate that clinical endpoints were not met in some Phase 3 studies of these product candidates.

KEYWORDS:

cancer; clinical studies; immunological disorders; monoclonal antibodies

PMID:
23727858
PMCID:
PMC3906304
DOI:
10.4161/mabs.24990
[Indexed for MEDLINE]
Free PMC Article

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