By: Patricia Keegan, M.D.
I have been with FDA for more than 20 years and an oncologist for 30 years. During this time, I have witnessed an evolving change in our understanding of cancer. We once viewed cancer as a single disease, such as breast or lung cancer. Today we understand that most cancers that arise in a single organ or area of the body are often a genetically diverse group of cancers that have different patterns of spread, different rates of growth, and different responsiveness to treatment.
To understand the progress we've made today in breast cancer, one has to look back at how changes in treatment expectations among oncologists, emerging scientific discoveries, and greater influence and advocacy from patients all fundamentally changed the nature of cancer drug reviews at FDA.
The late 1980s and early 1990s represented a dramatic shift in how oncologists began thinking about what treatments could achieve. Before this time, the effectiveness of a treatment was often measured by its ability to shrink a tumor, rather than its ability to extend a patient's life or prevent the cancer from spreading, which is a common expectation of treatment today. In addition, effective drug treatment was often limited to extremely toxic chemotherapies that generally killed healthy cells and cancer cells indiscriminately, further compromising the quality of life for patients with cancer.