Monoclonal antibodies therapeutic uses

After the approval of the first product, recombinant insulin, in 1982, progress in the development of new recombinant protein pharmaceuticals was slow ([10], Fig. 17.1). The number of biotechnology-derived drugs and vaccines approved by the US Food and Dmg Administration (FDA) has increased significantly only since 1995. More recently, sales of biologies have skyrocketed, e.g. from 900 million in 1999 to an estimated 3.5 billion in 2001 for monoclonal antibodies [11]. The annual global market for biopharmaceuticals is estimated to have increased from 12 billion US to 30 billion US in 2003 [12]. 500 candidate biopharmaceuticals are undergoing clinical evaluation and over one hundred protein-based therapeutics are in the... 

The ground-breaking development of monoclonal antibodies by Kohler and Milstein [21] initiated the development of antibody-mediated therapeutics for cancer. Because of their unique specificity, MAb were predicted to become the magic bullets in the battle against cancer. Over the last two and a half decades MAbs have moved from clone to clinic for the treatment of various malignancies. Several MAbs are currently entering clinical trials and should appear on the market in the next few years. The first MAb for cancer therapy was approved in the US in 1997. 

The use of monoclonal antibodies as therapeutics has become commonplace. Antibodies or chi meric proteins against TNF-a are very effective in quelling certain inflammatory diseases. Trastuzumab (against HER2) is effective in reversing the growth of some breast tumors. As of 2005, there were 15 antibody therapeutics approved for use in the US. 

Table 16.1 Therapeutic monoclonal antibodies approved by the US FDA. (Products with an annual turnover of more than US ...

We believe that the increasing numbers of US market approvals of monoclonal antibodies (mAbs) and recombinant therapeutic proteins for the US market will encourage biotech firms to pursue novel therapies for an increasing number of indications. Eurthermore, sequencing of the human genome provides multiple new tar-... 

Reichert, J.M., Therapeutic monoclonal antibodies trends in development and approval in the US. Curr Opin Mol Ther 2002, 4(2), 110-118. 

Rituximab represents the most important scientific achievement of the past decade. It was the first therapeutic antibody approved for the treatment of cancer and specifically for N H L. The current IWRC for N H L had their origin with the rituximab response criteria. Clinical development was completed in record time. Dossiers were filed simultaneously in the United States and in Europe. The US fihng utilized an electronic format (computer-aided product license application, CAPLA). These and many other achievements during clinical development served to provide tremendous impetus to the monoclonal antibody research area. The renewed enthusiasm in this area has yielded many new Mabs with activity in both hematologic malignancies and in autoimmune diseases. Several of these have been approved (e.g. herceptin, alemtuzumab, mylotarg, others) and many others are under active investigation. 

Treatment results in childhood acute leukemia continue to be improved due to new therapeutic and diagnostic methods. An optical microscopy method with specific staining allows to classify acute leukemia into lymphoblastic and myeloid types and discriminate its subtypes according to principals of FAB-classification. A flow cytometry method with monoclonal antibodies staining allows us to discriminate different immunophenotypic subtypes of acute... 

Table 18.2 summarizes information about the 21 therapeutic monoclonal antibodies approved by the US Food and Drug Administration (FDA) as of 2007. 

Since the first monoclonal antibody, muromo-nab-CD3, was approved by the FDA in 1986, the average rate of approval has been exactly one monoclonal antibody per year. There are currently many more therapeutic monoclonal antibodies under development and in phase II and III trials. As science and technology provide us with even more of these unique compounds over the years, great promise exists for the treatment and even cure of diseases that have proven to be refractory so far. One notable recent development in this field is the research being conducted on bapineuzumab, a monoclonal antibody with the potential to treat Alzheimer s disease. 

Pharma biotechnology Red biotechnology Monoclonal antibodies, other therapeutic proteins, vaccines, insulins, pDNA >170 billion US CAGR 12% >6000... 

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