FDA warns GSK over promotional claims regarding Tykerb

WASHINGTON The Food and Drug Administration stated that GlaxoSmithKline left out important safety information in promotional materials the manufacturer sent to health care professionals concerning its new breast cancer drug Tykerb.

“These letters, which were part of the launch campaign for Tykerb, are misleading in that they omit and minimize the most serious and important risk information for Tykerb and selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug,” the FDA said in the Nov. 21 warning letter.

The drug was approved in March to be used in combination with Roche Holdings’ cancer drug Xeloda in women with breast cancer who test positive for a protein called HER2 and who haven’t responded to prior treatment with other drugs. The drug is taken in a 21-day cycle.