ABSTRACT
Approved and commercialized nanomedicine The Food and Drug Administration (FDA) assesses the clinical trial data of a potential nanoparticulate drug like any other small-molecule drug candidate before it decides as to whether the drug should be approved. The number of such nanomedicine products being submitted for approval by the FDA is rapidly growing. Commercialization of the approved nanodrugs for treating critical human diseases has also made a signicant progress, with many nanotherapeutics currently seen in clinics. Cancer nanotherapeutics represent the biggest group, constituting more than 20% of the therapeutic nanoparticulate drugs in the clinics and predominantly include liposomal and micellar forms of poorly bioavailable anticancer drugs, such as paclitaxel, or anticancer agents with serious side effects, such as doxorubicin or daunorubicin. Indeed, the nanoparticle-based drug delivery systems have enhanced the therapeutic activities of these drugs by dramatically improving their pharmacokinetics, bioavailability, and tumor-directed delivery through either passive or active targeting, while simultaneously reducing their side effects. The clinically approved nanotherapeutics predominantly include liposomal or albumin-based formulations of anticancer drugs; antibody-drug conjugates; therapeutic monoclonal antibodies (e.g., Herceptin); therapeutic proteins that are glycosylated (e.g., Aranesp), PEGylated, amino acid substituted, or Fc-fusion based (e.g., Enbrel); and recombinant vaccines (Table 14.1).
