The discovery of a magic cancer drug called Glivec 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.
Some say it’s a miracle cancer drug. Others call it a silver bullet. Glivec, also marketed in US as Gleevec and sometimes referred to by its chemical name imatinib, entered the medical world with a bang. This medication was initially approved for use by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of chronic myelogenous leukemia (CML), a rare form of cancer that affects certain types of white blood cells. Since its initial approval, Glivec has also been approved for use in patients with several types of gastrointestinal tumors. Currently, scientists continue to study this cancer drug’s effectiveness in other diseases and types of cancer.

“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.”
–Dan Longo, M.D., professor of medicine, Harvard Medical School and deputy editor, the New England Journal of Medicine
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. Before the introduction of imatinib, a diagnosis of CML amounted to a death sentence. Now, most cases of CML can be controlled, and researchers have developed new medications to counter resistance to the drug when it arises.
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 Glivec, 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.”
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.”
In addition to treating patients with CML, Glivec 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 Glivec 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.”
My personal takeaway: Academia, Pharma and Healthcare institutions like the National Cancer Institute in the former case should work together in partnership I’m order to advance healthcare for the unmet needs. As part of the pharmaceutical industry I am really proud of being part of innovation at the service of health and I believe more should be done, better and faster to make new drugs available to patients worldwide… and to recognize the fundamental role of the pharmaceutical industry in the advances of healthcare.
What do you think about the public awareness/recognition of the role of Pharma in Healthcare?