Dx at heart of high-profile NHS drug approval
This article was originally published in Clinica
Executive Summary
It is extremely rare that a high-profile approval of a pharmaceutical for NHS use is as dependent on diagnostic testing and monitoring as that of Herceptin, as recommended today by the National Institute for Health and Clinical Excellence (NICE). According to the draft guidance, the use of trastuzumab for early HER2-positive breast cancer will be subject to tight cardiac function parameters that are to be assessed prior to treatment, and then every three months.