Bristol Myers Squibb and ImClone Systems receive approval for Erbitux

Bristol-Myers Squibb (BMS) and ImClone Systems have announced that the US Food and Drug Administration (FDA) has approved the updated product labeling for Erbitux (cetuximab).

Erbitux, produced by BMS in partnership with ImClone, will now display overall survival data when used in the treatment of epidermal growth factor inhibitor (EGFR)-expressing metastatic colorectal cancer (mCRC) patients after failure of both irinotecan and oxaliplatin-based regimens.

Eric K Rowinsky, senior vice president of ImClone Systems, expressed his delight that the FDA had recognised the improved overall survival results of Erbitux and that it had given its approval.

“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.”

Erbitux’s approval for a supplemental biologics license application (sBLA) follows a phase III trial comparing Erbitux and best supportive care (BSC) with just BSC alone.

In 572 EGFR-expressing mCRC patients who had seen failure of irinotecan- and oxaliplatin-based regimens, Erbitux displayed prolonged overall survival.

In July 2007, Bristol-Myers Squibb and ImClone Systems announced an expansion to their previous development and promotion agreement for Erbitux, with further investment agreed for clinical development of the drug.