FDA adds survival data to Erbitux product labeling
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
ROCKVILLE, MarylandFDA 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.
FDA Approves Encorafenib/Cetuximab Plus mFOLFOX6 for Advanced BRAF V600E+ CRC
December 20th 2024The FDA has granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
