FDA adds survival data to Erbitux product labeling

ROCKVILLE, Maryland—FDA has approved a supplemental biologics license application for ImClone and Bristol-Myers Squibb's Erbitux (cetuximab) to add monotherapy survival data to the agent's labeling. The decision is based on a phase III study showing prolonged overall survival for single-agent Erbitux among 572 patients with EGFR-expressing metastatic colorectal cancer randomized to Erbitux or best supportive care after failure of irinotecan (Camptosar)- and oxaliplatin (Eloxatin)-based regimens.

"Erbitux is now the only approved biologic therapy to demonstrate improved overall survival as a single agent in patients with metastatic colorectal cancer," said Bristol-Myers Squibb's Martin Birkhofer, MD.