On May 25, 2007, the European Medicines Agency advised against approving Amgen’s new cancer drug Vectibix because its benefits do not offset its risks. A committee within the agency was concerned there was not enough evidence to prove Vectibix was beneficial.

Vectibix is a chemotherapy medicine given through an IV to kill cancer cells from the colon or rectum that have spread to other areas of the body after treatment with standard chemotherapy.

The regulator of the study said the drug did not significantly increase the time before the disease worsened. In addition, the study found the drug increased side effects, like skin reactions.

Amgen said it will appeal the agency’s decision.

The U.S. Food and Drug Administration approved Vectibix for sale in the United States in September 2006.

Source: Anita Greil, “European regulator deals setback to Amgen cancer drug,” Wall Street Journal, May 25, 2007; “Questions and answer on recommendation for the refusal of the marketing authorization for Vectibix,” European Medicines Agency, May 25, 2007.