Breast Cancer Drug Failed In Food And Drug Administration Studies

Breast Cancer Drug Failed In Food And Drug Administration Studies

WASHINGTON, D.C. -

On Friday, the Food and Drug Administration announced that their follow up studies on the breast cancer drug from Roche failed to show the slowing of tumor growth or to have the ability to extend an individuals life, who had breast cancer. As a result, the is a possibility that the drug could be withdrawn from the study and the possibility of it being marketed could go down the drain as well.

In 2008, Avastin was approved by the Food and Drug Administration, which was Roche's blockbuster, and based on the early trails it showed that it could shrink tumors that were caused by breast cancer. However, the decision to approve the drug was quite controversial since drugs in the past for cancer patients that have never been treated before normally show signs that the drug will extend their lives.

The approval on Avastin was called an accelerated approval and was based on one condition, which was that later studies would show the survival benefits. However, two of the follow up studies failed to show that Avastin actually did extended a cancer patients life compared to only chemotherapy.

Also, the Food and Drug Administration announced that the recent data they received had not confirmed the shrinking of tumors they had seen in earlier stages. More side effects were being shown in patient who were taking Avastin, which included high blood pressure, fatigue, and abnormal levels of white blood cells.

A panel of cancer experts will review the evidence on Avastin on Tuesday for the Food and Drug Administration, but this does not mean that the panel's recommendations will be binding. However, the Food and Drug Administration normally does follow their aid and guidance though.