FDA approves Amgen colon cancer drug

09/28/06 - newratings.com

NEW YORK, September 28 (newratings.com) – The US Food and Drug Administration (FDA) Wednesday approved Amgen Inc’s (AMGN) drug, Vectibix, for the treatment of colon cancer in patients who are undergoing chemotherapy treatment.

The Thousand Oaks, California-based company's drug binds to a protein on certain cancer cells and may either slow or stop the growth of some tumours. The FDA has granted an accelerated approval on the basis of a clinical trial, which had 463 patients. The size of the tumours declined by more than 50% in 8% of the patients who were administered Vectibix. Dr Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a statement, "This approval adds a treatment option for patients with an advanced stage of a disease that can be life-threatening." Amgen is also seeking approval for Vectibix in Europe, Canada, Australia and Switzerland.