PORTLAND, Ore. - In 2001 the U.S. Food and Drug Administration granted priority review for imatinib mesylate, sold under the name Gleevec®*, as an oral therapy for patients with chronic myeloid leukemia, or CML.
Today the New England Journal of Medicine published results from a nearly 11-year follow-up study, that showed an estimated overall survival rate of 83.3 percent. According to the National Cancer Institute, prior to Gleevec's 2001 FDA approval, fewer than 1 in 3 CML patients survived five years past diagnosis.
Brian Druker, M.D., who led the original clinical development of Gleevec, co-authored the study. The worldwide study enrolled 1,106 participants at 177 cancer centers in more than 16 countries.
"The long-term success of this treatment confirms the remarkable success we've seen since the very first Gleevec trials," said Druker, director of the OHSU Knight Cancer Institute, a Howard Hughes Medical Institute Investigator and JELD-WEN Chair of Leukemia Research in the OHSU School of Medicine. "This study reinforces the notion that we can create effective and non-toxic therapies."
The discovery of Gleevec ushered in the era of personalized cancer medicine, proving it was possible to shut down cells that enable cancer to grow without harming healthy ones.
In an accompanying editorial, "Imatinib Changed Everything," Dan Longo, M.D., professor of medicine, Harvard Medical School; and deputy editor, the New England Journal of Medicine, wrote: "The development of imatinib fundamentally altered the field of oncology. Priorities shifted from agents that were active on dividing cells to understanding the biology of individual types of cancer."
In addition to treating patients with CML, Gleevec has proved effective against multiple forms of cancer, including pediatric CML and gastrointestinal stromal tumor, or GIST. A recent study published in JAMA Oncology found that nearly 1 in 4 GIST patients treated with Gleevec will survive 10 years.
"Until Gleevec arrived on the scene 15 years ago, patients with advanced GISTs faced a life expectancy of 18 months," said Michael Heinrich, M.D., a professor of medicine (hematology and medical oncology) and cell and developmental biology in the OHSU School of Medicine; researcher with Portland Veterans Affairs Health Care System. "Now we've learned that some might live a decade or longer."
Druker says one advantage to treating CML patients with Gleevec is that most patients are diagnosed in a chronic stage of their illness: "Our results demonstrating Gleevec's high efficacy in CML tell us to realize the full promise of precision cancer medicine, we need to diagnose and treat patients earlier in the disease course."
* Gleevec is a trademark of Novartis Pharmaceuticals Corporation
Particulars: Funding for the study was provided by Novartis Pharmaceuticals; IRIS ClinicalTrials.gov numbers NCT00006343 and NCT00333840; OHSU IRB number e1091.
In the interest of ensuring the integrity of our research and as part of our commitment to public transparency, OHSU actively regulates, tracks and manages relationships that our researchers may hold with entities outside of OHSU. In regards to these research projects with Novartis, Drs. Druker and Heinrich receive a share of licensing revenue for use of Gleevec for GIST. Dr. Heinrich is a consultant to Novartis and has provided expert testimony for Novartis. Review details of OHSU's conflict of interest program to find out more about how we manage these business relationships.
About the Knight Cancer Institute
The Knight Cancer Institute at OHSU is a pioneer in the field of precision cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down just the cells that enable cancer to grow. This breakthrough has made once-fatal forms of the disease manageable and transformed how cancer is treated. The OHSU Knight Cancer Institute is in the process of building a large-scale early cancer detection program following the successful completion of the $1 billion OHSU Knight Cancer Challenge. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle - an honor earned only by the nation's top cancer centers. It is headquarters for one of the National Cancer Institute's largest research collaboratives, SWOG, in addition to offering the latest treatments and technologies as well as hundreds of research studies and clinical trials. For additional information on the OHSU Knight Cancer Institute visit http://www.