Are current drug development programmes realising the full potential of new agents? The scenario.

This was most clearly seen in the pivotal clinical trial of trastuzumab in HER2-positive metastatic disease in which only 145 patients were needed to show both a highly significant progression-free survival and overall survival benefit for the addition of the monoclonal antibody to paclitaxel chemotherapy as first-line therapy [ 4 ].

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