members of the FDA's oncology Drugs Advisory Committee cautioned sponsors against treating retrospective clinical trial biomarker analysis like an exercise in data dredging.
The committee met last month go consider the adequacy of retrospectivly mined data in determining whether a biomarker is truly predictive of patient response. The discussion stemmed from a retrospective data analysis conducted to show that the KRAS biomarker status of patient tumors helps predict responses to Amgen's Vectibix (panitumumab) and ImClone and Bristol-Myers Squibb's Erbitux (cebuximab) cancer drugs.
See meeting transcribts here or the slides.
In other news, the US FDA encourage the integration of biomarkers in drug development and their appropriate use in clinical practice.