Jane S. Ricciuti, RPh, MS


April 05, 2004

In This Article


The US Food and Drug Administration (FDA) approved 2 new anticancer agents to be used with currently approved regimens -- Avastin (bevacizumab) and Erbitux (cetuximab).

Bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum. Bevacizumab is a recombinant monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF).

Cetuximab is indicated for the treatment of epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Cetuximab is a monoclonal antibody that targets EGFR-expressing cancer cells.

This month's column reviews FDA new product approvals and labeling changes for:

Anticancer Agents

  • Avastin (bevacizumab) Injection

  • Erbitux (cetuximab) Injection

Cardiovascular Agents

  • Caduet (amlodipine/atorvastatin) Tablets

Central Nervous System Agents

  • Provigil (Modafinil) Tablets

Immune Globulin

  • Rhophylac (Rho[D] Immune Globulin Intravenous [Human])

Osteoporosis Agents

  • Actonel (risedronate sodium) Tablets