Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Jul 20, 2009

FDA Says Erbitux No Good for Those with Certain K-ras Mutations

  • FDA has made changes to the U.S. prescribing information for Erbitux with regards to treating those with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC). The label states that the drug is not recommended for patients whose tumors have K-ras mutations in codon 12 or 13.

    FDA’s revisions included a statement that retrospective subset analyses of metastatic or advanced colorectal cancer trials did not show a treatment benefit for Erbitux in patients whose tumors had these K-ras mutations. These modifications were also made to the clinical studies and clinical pharmacology sections of the product’s prescribing information.

    About 40% of patients with mCRC have K-ras mutations, according to ImClone and Bristol-Myers Squibb, the companies that market Erbitux. Signal transduction through the EGFR results in activation of wild-type K-ras protein. In cells with activating K-ras somatic mutations, however, the mutant K-ras protein is continuously active and appears independent of EGFR regulation.

    In mCRC Erbitux is approved by the FDA as: a single agent for EGFR-expressing mCRC after failure of both irinotecan- and oxaliplatin-based regimens; a single agent for EGFR-expressing mCRC in patients who are intolerant to irinotecan-based regimens; and in combination with irinotecan for the treatment of EGFR-expressing mCRC in patients who are refractory to irinotecan-based chemotherapy.



Related content

Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »