Welcome news to women with so-called triple-negative breast cancer a type of breast cancer more likely to resist commonly-used treatments: According to a new guidance issued this week by the FDA, pharmaceutical companies will now be allowed to test their cancer drugs on these patients before they undergo surgery. This is in contrast to current rules stipulating that drug makers must wait to treat early-stage cancer patients until the treatment has first been proven effective among those with late-stage, metastatic forms of the disease.
Drafted by Dr. Richard Pazdur, director of the FDA s cancer drug office, and Dr. Tatiana Prowell, a medical officer for the FDA, the guidelines can be found in the current issue of the New England Journal of Medicine. We re looking at introducing drugs into a very early stage of breast cancer, where a patient has a primary tumor and the chemotherapy is given before surgery, explained Dr. Pazdur of the latest initiative. The aim of this therapy would be to cure the woman of breast cancer.
If such tested drugs are indeed successful at eliminating any signs of the cancer in the breast or lymph nodes as determined at the time of surgery (termed pathological complete remission), the makers would be eligible to obtain accelerated approval.
Since women with triple-negative breast cancer have a less treatable form of the disease (unresponsive to most breast cancer drugs), the latest guidelines are directed only at these patients. Those who have the highest risk of relapse are the most likely to benefit from early treatment if, that is, the treatment proves effective and not overly toxic.
ACSH's Dr. Gilbert Ross was pleased to read about the FDA s latest initiative, and is happy to note that the agency is thinking outside the box by initiating a new drug treatment paradigm geared toward women with this type of breast cancer, which is typically so difficult to treat.
