The health sector continues to be one of the most challenging field in the research work. The magnitude of the diseases, in the society, is posing challenges and the research teams are in the process of developing newer drugs that have improved efficacy and propensity in combating diseases. One of the recently release drugs by Food and Drug Administration is ado-trastuzumab emtansine, which was approved on February 22, 2013.
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The drug generic name is ado-trastuzumab emtansine, and the marketing name is Kadcyla. The drug is a HER2-target antibody-drug conjugate used in treating breast cancer. According to RxList.com (2013), the drug plays a critical role in controlling development of cancerous cells in human breast especially those promoted by HER2 IgG1. FDA argues that the drug is a consummate humanized anti-HER2 IgG1 modified trastuzumab. However, restrictions to administration and prescription of this drug allows only patient who have HER2 positive metastatic breast cancer and who have been on Trastuzumab and taxane treatment. Once these drugs fail to deliver positive consequences, the physician may prescribe this drug. According to FDA recommendations the patient should take a dose of 3.6 mg/kg body weight in a span of 21 days, which should be repeated till effective or intolerable toxicities are encountered.
Chames, Regenmortel, Weiss and Baty (2009) in their study emphasized the imperativeness of conducting substantial clinical trials and laboratory test for any drugs to validate feasibility, efficacy and evaluate the possible side effects and adverse effects before releasing it to the market. Food and Drug Administration (FDA) is the body bestowed with the responsibility of approving drugs in U.S. Kadcyla underwent a series of studies before its approval. The drug manufacturing is engineered on the bases of stopping the metastasis of breast cancer cells among other condition. The rationale behind the mode of engineering is that the component trastuzumab binds to HER2 arresting the growth of the cells while mertansine component of the drug attaches to tubulin killing the cells. The drug cannot affect healthy cells since the targeted factors are only expressed by cancerous cells. The drug was proven to raise survival rate to by a substantial rate.
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