FDA may insist on KRAS tests for cancer patients

The US Food and Drug Administration is considering alterations to the labeling of certain cancer drugs to discourage their use in patients who are unlikely to benefit from them because of their genetic profile.

The FDA's Oncologic Drugs Advisory Committee is discussing whether US drug majors Eli Lilly and Bristol-Myers Squibb's Erbitux (cetuximab) and biotechnology firm Amgen's Vectibix (panitumumab) will have new labeling added that will suggest that colon cancer patients are screened for the KRAS gene mutation - which can counteract the efficacy of the treatments - before they are prescribed the drugs.

"The selection of a drug based on genomic biomarker profile is desirable because it limits drug exposure to patients who will benefit/are most likely to benefit from drug treatment, avoids drug use in patients who will be/are likely to be harmed by drug treatment or enhances safe use by optimizing drug dosing," the FDA noted.