The approval of the supplemental biologics license application 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 metastatic colorectal cancer patients after failure of irinotecan and oxaliplatin-based regimens.
Eric Rowinsky, chief medical officer and senior vice president of ImClone Systems, said: “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.”
Martin Birkhofer vice president, oncology global medical affairs, Bristol-Myers Squibb, said: “Erbitux is now the only approved biologic therapy to demonstrate improved overall survival as a single agent in patients with metastatic colorectal cancer. We continue to be encouraged by the benefits of Erbitux in metastatic colorectal cancer, and are actively exploring its potential in other tumor types.”