FDA To Allow Early Onset Testing of Breast Cancer Drugs

Posted on June 8, 2012

Women suffering from a certain type of aggressive breast cancer are going to be able to get their hands on new drugs faster than would have previously been possible.

That’s because the Food and Drug Administration released a guidance document recently that allows various drug companies to test new drugs on women with a specific type of breast cancer before they have surgery.  Typically, drug manufacturers have first had to prove an item’s safety and efficacy on patients that have more advanced forms of cancer.  It would have taken nearly a decade for such drugs to make their way to patients with breast cancer in its early stages, according to an FDA official and cancer specialist with Johns Hopkins.

The new rule applies to those women who suffer from what’s known as triple-negative breast cancer, a designation which comes about when tumors don’t have HER2 receptors, estrogen, or progesterone, a necessity for most breast cancer drugs to be effective.  At-risk demographics include African-Americans and younger women.

The new drug trials would involve administration of the experimental drugs along with chemotherapy leading up to surgery, while the control group only received the chemotherapy.  If it turns out that the drugs in question show progress toward getting rid of cancer in the breast or lymph nodes, the drug companies could find themselves gaining accelerated approval of their drugs.

The new model is discusses in the newest issue of the New England Journal of Medicine.

How Can We Help You?

If you have a legal matter you would like to discuss with an attorney from our firm, please call us at (310) 477-1700 or complete and submit the e-mail form below, and we will get back to you.

  • This field is for validation purposes and should be left unchanged.
  • This field is for validation purposes and should be left unchanged.
*Required Fields