FDA approves Erbitux for colorectal cancer after standard treatment fails

Based on research that showed Erbitux® (cetuximab) improved survival compared to best supportive care in patients with advanced colorectal cancer who had already had their cancer get worse with standard chemotherapy treatments,  the Food and Drug Administration has approved a change in Erbitux labeling.  The label will now reflect improved survival when Erbitux is used alone  to treat patients after failure of irinotecan and oxaliplatin regimens.

Results from a phase III clinical trial of cetuximab used alone compared to best supportive care for patients who had no other remaining standard treatment options was reported during the 2007 meeting of the American Association for Cancer Research.

In that study. 572 patients were randomly assigned either to receive cetuximab by IV every week or to have best quality supportive care. Supportive care was designed to reduce symptoms but not directly treat tumors.  All patients had previously been treated with chemotherapy regimens that included irinotecan and oxaliplatin, as well as 5FU or capecitabine.

Cetuximab  improved overall survival by 23 percent.  Median survival with cetuximab was 6.1 months compared to 4.6 months with supportive care.

There was also an improvement in the time before the cancer began to progress with cetuximab.  Nineteen patients (6.6 percent) had their tumors shrink partially with cetuximab, but none had a similar response with supportive care.

Serious side effects that were more frequent in the cetuximab group included rash, infection, confusion, pain, and low magnesium levels.  Twelve percent of patients had a severe (grade 3) rash.

Cetuximab targets the epidermal growth factor receptor (EGFR) on cancer cells, blocking a pathway that leads to cell division and cancer growth.

A video webcast of Dr. Derek Jonker’s presentation at AACR 2007 can be found by on the American Association for Cancer Research website.

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