Many of us are aware of the newly approved drug Zytiga (abiraterone). It had demonstrated a survival advantage for men who are castrate resistant and failed chemotherapy. Zytiga was approved by the FDA in April and many of us with advanced prostate cancer have been taking advantage of the drug. You can learn more about Zytiga by searching for it in this blog.
MDV3100 another new investigational drug with a similar methods of action has already begun its phase 3 trials. Since the studies of MDV3100 have targeted men who are similar to those who are taking Zytiga, the press has bantered about the possibility that MDV3100 will be too late on the market when and if it is ultimately approved by the FDA.
However, Medivation Inc, which expects key data this year from a pivotal trial believes that could have a competitive advantages over Zytiga. Earlier this year they readjusted their Phase 3 trial of MDV3100 with the goal of triggering an interim analysis during 2011. Their hope is that the survival data will be strong enough to allow them to obtain early FDA approval.
“We want to do whatever we can to make our drug available to as many patients as possible,” Medivation Chief Executive Officer David Hung told Reuters in a telephone interview. “It is always good to minimize the lead of a competitor.”
The Zytiga trial of 1,195 patients — designed to show at least a 20 percent reduction in the risk of death — ended up demonstrating a 35 percent benefit.
The 1,199-patient Medivation study is “very, very similarly powered,̶