In Untitled Letter, FDA Tells Bristol-Myers Breast Cancer Drug Materials Misleading

A sales aid for the breast cancer drug Ixempra (ixabepilone) is misleading, the Food and Drug Administration said in an untitled letter sent to Bristol-Myers Squibb in late June.

The letter, dated June 29, was posted online by the agency recently. FDA said its Office of Prescription Drug Promotion said the sales aid is misleading because it has unsubstantiated efficacy claims and broadens the indication for the drug. These violations misbrand the drug, the agency said.

The sales aid is called “Monotherapy/Combination Therapy Sales Aid 3.” According to a Bristol-Myers website, Ixempra is used to treat locally advanced or metastatic ...