ImClone, BMS revise U.S. prescribing info of cancer drug

NEW YORK The Food and Drug Administration has approved changes to the prescribing information for a biotech drug used to treat cancers, in light of analyses showing the drug to be ineffective in colorectal cancer patients, whose tumors include a certain gene mutation.

ImClone Systems and development partner Bristol-Myers Squibb announced revisions to the U.S. version of the prescribing information for Erbitux (cetuximab) Monday in light of analyses showing that the drug may not work for patients with metastatic colorectal cancer that includes the epidermal growth factor receptor, also known as EGFR, and whose tumors include the K-ras gene mutation.

The American Society of Clinical Oncology and the National Comprehensive Cancer Network recently issued guidelines recommending that metastatic colorectal cancer patients be tested for the K-ras mutation before receiving anti-EGFR monoclonal antibodies, the class of drugs that includes Erbitux.