Headline Confidence in Medarex's ipilimumab dented again
Source EP Vantage
Company Medarex, Bristol-Myers Squibb 
Date April 28, 2008
 

Medarex’s and Bristol-Myers Squibb’s ipilimumab, which was going to be filed in the US this year in second-line metastatic melanoma, could be set back by two years by the FDA’s request to see additional overall survival data demonstrating the drug’s benefit.

Whether the decision has left the project looking more risky is another matter, as the filing planned for this year was based on unspectacular data, and had a high chance of being turned down. It does, however, make the results of an ongoing phase III trial, due to conclude mid-2009, even more critical. And unfortunately for Medarex, it will heighten concerns the drug faces the same fate as Pfizer’s tremelimumab, which was abandoned earlier this month.

 

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