Survival Data in FDA Approval for ERBITUX(R) (Cetuximab) Supports use as a Single Agent in Patients with Advanced Colorec...( NEW YORK Oct. 2 /- ImClone System...),Health

NEW YORK, Oct. 2 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the ERBITUX(R) (Cetuximab) product labeling to include overall survival data as a single agent in epidermal growth factor inhibitor (EGFR)-expressing metastatic colorectal cancer (mCRC) patients after failure of both irinotecan- and oxaliplatin-based regimens.

The approval of the supplemental biologics license application (sBLA) is based on prolonged overall survival from a large, randomized, multicenter, Phase III trial comparing ERBITUX plus best supportive care (BSC) to BSC alone in 572 EGFR-expressing mCRC patients after failure of irinotecan- and oxaliplatin-based regimens. BSC was considered to be all approved palliative therapies designed to alleviate pain and treat other effects caused by mCRC in this patient population.

"We are very pleased that the FDA has recognized these data as the second disease setting where ERBITUX has improved overall survival - which is the ultimate goal of all cancer therapies," said Eric K Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems. "This approval for ERBITUX as a monotherapy offers an additional treatment option for an expanded patient population, specifically, patients who have failed both irinotecan- and oxaliplatin-based chemotherapy regimens."

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