Sunday 20 May 2012

MDV3100 Versus Provenge

MDV3100 versus Provenge - Which is more Hyped ?

Both the manufacturers of MDV3100 (Medivation) and Provenge (Dendreon Corp) dramatically over hype their products, but which one of them is the most overhyped. Here we look at the evidence for any benefits at all of efficacy of these agents.

Provenge - works as a cancer vaccine to prime the immune cells to attack the cancer. Well thats the theory but what effects does it have in clinical practise against prostate cancer. There is actually little evidence that Provenge offers any life extension or can even reduce PSA levels. Many men are given false hope with Provenge and their PSA levels continue to rise unabated. So where is the evidence that Provege even works at all.

MDV3100 (Enzalutamide) - works as an antiandrogen. This is an analogue of the antiandrogen casodex and could be used for treating casodex relapsed patients. However there is a high relapse rate on MDV3100 so it is unlikely that this drug will provide benefit for longer than a few months. In phase 3 clinical studies MDV3100 did show extension of overall survival of 6 months which is impressive. However there was a 0.6% rate of heart seizures on the MDV3100 treated arm compared to 0% in the placebo arm. This is a highly significant rate of heart failure and amounts to 6 people in a patient population of 1000 which may limit its widespread long term use. Although these cardiotoxicity statistics are being brushed under the carpet by the manufacturers they will surely manifest upon widespread usage as was the case for the antiinflammatory drug VIOXX from Merck which went into widespread usage but had to be withdrawn suddenly from the market due to cardiotoxicity problems.

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