FDA Warns GSK Over Promotional Materials
GlaxoSmithKline (GSK) selectively presented efficacy data and omitted important risk information in a letter to physicians announcing the launch of Tykerb, a kinase inhibitor indicated for the second-line treatment of HER2-positive metastatic breast cancer, according to the FDA.
Tykerb (lapatinib) was launched in March as the first targeted, once-daily oral treatment for the HER2-positive breast cancer population. GSK recorded $64 million in sales for the drug as of Sept. 30, with $48 million in the U.S. The promotional materials in question, previously submitted to the agency in a Form FDA 2253, announced the availability of the drug, presented clinical trial data and listed common adverse events associated with Tykerb.
The materials are misleading, according to the letter, sent Nov. 21 and posted on the agency’s website Nov. 26. “The promotional letters make prominent claims of effectiveness for the treatment of advanced or metastatic breast cancer but fail to present the most serious and important risk information from the [package insert],” the FDA said.
GSK overstated the drug’s efficacy by presenting only one of two assessments of clinical effectiveness, the agency said.
GSK said the promotional materials were not misleading and included important safety and efficacy information but are no longer in use. At the time of their distribution, the firm said it thought it was important to notify physicians about the product, a treatment for a life-threatening condition when patients have failed prior therapy.
The warning letter can be viewed at www.fda.gov/cder/warn/2007/Tykerb_wl.pdf.
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