FDA Questions Effectiveness of Breast Cancer Drug

Friday, August 13, 2010 by: Megan Rostollan
Tags: breast cancer, drugs, health news

(NewsTarget) The Food and Drug Administration went public with its doubts about the effectiveness of a relatively new breast cancer drug (1). This drug was approved in 2008 after a clinical trial showed that it slowed the progression of breast cancer tumors. Initially the drug appeared promising and it was approved for treatment of breast, lung, colon, kidney, and brain cancers. The drug was the top selling cancer treatment last year for the manufacturing company, with total sales of 5.9 billion dollars world-wide and approximately 1.2 billion of that revenue coming from its use in the treatment of breast cancer (2). Now follow-up studies are failing to show that the drug extends the lives of cancer patients and the FDA is considering withdrawing its prior recommendation of this particular drug for use in treating breast cancer.

The drug was put through an accelerated approval process back in 2008 and its continued use was contingent on later drug trials confirming its effectiveness in extending the lives of breast cancer patients. Now that this ability is in question the continued use of the drug for treating breast cancer is as well. FDA reviewers said that follow-up studies submitted to them by the pharmaceutical company failed to show that the drug extended life expectancy in breast cancer patients, saying that those studies "failed to confirm the magnitude of (progression-free survival) improvement" that was seen in earlier breast cancer trials.

Early trials showed that patients' progression-free survival rate increased by 5.5 months on the drug in question. In later studies these numbers ranged from one month to under three months, which is not considered clinically meaningful.

Additionally, patients taking the tumor-starving drug showed potentially serious side effects, which included high blood pressure, fatigue, and problems with white blood cell levels (3). Other risks include gastrointestinal perforations, blood clots, and bleeds, when the drug is combined with chemotherapy treatment; these are risks the FDA is not certain are worth the potential benefits.

The FDA asked a panel of outside experts to analyze the data on the drug, and the outcome is expected to heavily influence the FDA's final decision about the drug. It is not expected that this cancer treatment will be removed from the market entirely, but its use in treating advanced breast cancer may no longer be recommended.

References:

1.http://tinyurl.com/2dgu4uj
2.http://tinyurl.com/24x5mju
3.http://www.usatoday.com/news/health/2010-07-...

About the author

Megan Rostollan is a Certified Family Herbalist and works with her husband David, a private natural health and nutrition consultant (www.reforminghealth.com). She is also the author of a blog which can be found at NaturalHousewifery.com. Her areas of greatest interest include women's reproductive and prenatal health, as well as organic and green living and dietary and lifestyle changes.