FDA scolds GSK for hyping cancer drug

While GlaxoSmithKline is supplicant at the FDA on one hand, it's getting slapped on the other. The agency warned GSK that its marketing for the breast cancer drug Tykerb is out of hand. E-mail and letters sent to doctors and oncology nurses as part of the drug's launch left out the drug's most serious risks and exaggerated its efficacy, the agency says. That all-important first impression suggested that Tykerb is safer and more effective than it really is, the letter states.

What was left out? First, Tykerb can cause severe diarrhea, which is significant because doctors and nurses might want to order preventive meds or hydration. Second, patients with impaired liver function might require lower doses of Tykerb. And, perhaps most importantly, GSK's marketing materials failed to mention the risk of a particular heart problem known as decreased LVEF, or left ventricular ejection fraction. Patients using Tykerb are supposed to be screened for LVEF problems ahead of treatment and monitored during it to make sure it doesn't decline too precipitously. As for the hype, Glaxo trumpeted a study showing 43 percent decrease in tumor-growth risk and left out the study that showed only 28 percent decrease.

- check out the warning letter [1] from the FDA
- read the report [2] from CNN Money

Related Articles:
Tykerb gains priority review. Report [3]
GSK stakes claim to ASCO spotlight. Report [4]
GSK halts cancer trial on positive data. Report [5]