Bristol-Myers Squibb, Medarex set to seek FDA approval for their melanoma drug

January 3, 2008

New York - Bristol-Myers Squibb Co., based here, and Medarex Inc., Princeton, N.J., are reporting mixed results from three studies of the experimental drug ipilimumab for treating advanced melanoma, according to news source Reuters.

New York - Bristol-Myers Squibb Co., based here, and Medarex Inc., Princeton, N.J., are reporting mixed results from three studies of the experimental drug ipilimumab for treating advanced melanoma, according to news source Reuters.

Overall, however, the companies report that the study results are strong enough to seek Food and Drug Administration approval for the drug.

One of the three studies failed to meet its primary goal, which was to rule out a best objective response rate of less than 10 percent, the companies say. They add that the totality of the data, combined with limited treatment options for melanoma patients, likely will result in a filing seeking FDA approval by mid-2008.

The studies involved 487 patients with advanced metastasized skin cancer. While the one study failed to meet its goal, best objective response rates across the three studies ranged from mid-single digits to mid-teens, according to the companies.

Overall, the safety results from the three studies were consistent with data obtained from previously reported clinical trials of ipilimumab, the companies say, adding that the most common immune-related adverse side effects were rash, diarrhea and hepatitis.