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FDA changes labeling for cetuximab and panitumumab

Posted Jul 22 2009 12:00am

Finally, the FDA announced labeling changes to the anti-EGFR MoAbs cetuximab and panitumumab to reflect the overwhelming evidence supporting the benefit to patients receiving these drugs only with wild-type KRAS (recent CAP Today article).

Although still limited to patients with metastatic colorectal cancer, I suspect there will be more uptake of KRAS mutation testing since there was still some confusion out there on the "best" way to test for EGFR because of the delay of the FDA to change the labeling--months after NCCN and ASCO changed their guidelines.

Pathologists, oncologists, and patients should inquire about which methodology is being used because there are some critical differences.

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