50 Years of Progress in Treating Patients with Cancer
By Richard Pazdur, MD, Director, Oncology Center of Excellence (OCE) and Acting Director, Office of Oncologic Diseases (OOD)
This year, the U.S. National Cancer Institute (NCI), the FDA Oncology Center of Excellence and the broader oncology community are commemorating the 50th anniversary of the National Cancer Act (NCA) of 1971. This unprecedented legislation increased the nation’s commitment to supporting cancer research and drug development. The Act granted new authorities to the NCI, leading to NCI-supported cancer centers around the country and bringing the latest therapies and clinical trials closer to where people live. New funding supported innovative scientific research that led to insights into cancer biology and ultimately spurred development of therapies that were not even imaginable 50 years ago.
In 1971—one year after I graduated from high school—there were only a few FDA-approved cancer treatments. Only one of two people diagnosed with cancer at that time survived at least five years.1 When I began my medical career in 1979, about 35 drugs were available to treat cancer—mainly chemotherapies that were not very effective and often carried a lot of risk.
In the 1970s and 1980s, advances in medical imaging technologies like ultrasound, computerized tomography, magnetic resonance imaging, and positron emission tomography allowed for clearer views inside the patient’s body to gain accurate measurements of tumor shrinkage. These advances provided a better understanding of the effectiveness of therapies—or lack thereof.
But scientists went even deeper, with research into the human genome and tumor cell changes that could lead to cancer. In 1990, the National Institutes of Health (NIH) began the Human Genome Project and completed mapping this reference genome in 2003. In 1997, the NCI began the Cancer Genome Anatomy Project to develop an online database of normal, pre-cancerous and cancerous genomes.
With these large projects, coupled with basic scientific research by investigators all over the world in the early 2000s, we could now identify molecular features of an individual patient tumors that could be targeted with specific therapies.2 Advances in tumor sequencing technology have allowed us to look inside the genetic makeup of a patient tumor to identify mutations and tailor treatments. Types of cancer are increasingly narrowly defined by molecular subtypes, leading to “targeted” therapies that home in on specific genetic alterations in tumors and block molecular pathways that enable tumors to grow. Targeted therapies have improved survival in several types of cancer, including chronic myeloid leukemia, B-cell lymphoma, HER2-positive advanced breast cancer, and non-small cell lung cancer.
Now we are in the era of immunotherapy. These therapies train the immune system to recognize and attack cancer. Some types of cancer that do not respond to other therapies are being treated successfully with immunotherapies. In the past four years, FDA has approved truly personalized CAR-T therapies for types of leukemia and lymphoma. These therapies are tailored for each patient by removing the patient T cells (a type of immune system cell), genetically altering the cells to recognize specific antigens, growing the cells in a lab, and infusing them back into the patient to stimulate the immune system’s attack on the cancer cells.
Over just the past 22 years, since I joined FDA, the agency has approved more than 150 new molecular entities to treat cancer. Thanks in part to these therapeutic advances, there are more than 14 million cancer survivors in the U.S. today and more than two in three people diagnosed with cancer will live at least five years.1
No one wants to go back a half century to the days of nonselective chemotherapies, low response rates, and high toxicities. Cancer treatments have come a very long way in the past 50 years, but of course our work continues. At the FDA, we look forward to working with patients, industry, federal entities, and other stakeholders to develop drugs and ultimately improve the lives of people with cancer.
1 American Cancer Society: Advancement of Cancer Survivorship. Available at www.cancer.org/cancer/cancer-basics/history-of-cancer/cancer-survivorship.html.
2 Wheeler, David A, and Linghua Wang. From human genome to cancer genome: the first decade. Genome research vol. 23,7 (2013): 1054-62. doi:10.1101/gr.157602.113