ERBITUX® is approved for the treatment of certain patients who have colorectal cancer that has spread to other parts of the body. Only patients whose tumors are KRAS wild-type (which means they have a KRAS mutation-negative gene), and whose tumors have a protein called epidermal growth factor receptor (EGFR), should receive ERBITUX. An FDA-approved test is used to determine if tumors have these particular traits. Treatment with ERBITUX is given in the following ways:
ERBITUX is not approved to treat colorectal cancer in patients whose tumors have mutations in genes called RAS (often called "RAS mutant"), or in patients for whom the mutational status of the RAS genes is not known.
ERBITUX is approved in combination with encorafenib, for the treatment of adult patients with colorectal cancer that has spread to other parts of the body. Only patients whose tumors are BRAF V600E mutant (which means they have a BRAF V600E mutation-positive gene) and their condition has progressed from a previous treatment should receive ERBITUX with encorafenib. An FDA-approved test is used to determine if tumors have these particular traits.
ERBITUX is available by prescription only.
WARNING: ALLERGIC REACTIONS AND HEART ATTACK
ERBITUX can cause serious and sometimes fatal allergic reactions. Serious allergic reactions due to ERBITUX therapy occurred in 2.2% of patients receiving ERBITUX during clinical studies; 1 patient died. The risk of anaphylactic reactions may be increased in patients with a history of tick bites, red meat allergy, or in the presence of certain antibodies which can react to ERBITUX.
ERBITUX can cause heart attack or sudden death.