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Leukemia Drug Gets Priority Approval

Dr. Schiffer has been testing Gleevec at WSU and the Karmanos Cancer Institute and is delighted with preliminary results.

Dr. Charles Schiffer calls Gleevec the most dramatic development he's seen in 30 years as a leukemia specialist. After positive results in clinical trials, Gleevec was granted a priority review by the Food and Drug Administration, and was approved in just two months, making it the fastest approval of any cancer treatment to date.

Dr. Schiffer, professor of internal medicine and oncology, has been principal investigator for clinical trials of Gleevec at WSU since 1999. He says the drug has provided dramatic effects in treating Chronic Myelogenous Leukemia (CML), a disease caused by a specific mutation called the Philadelphia chromosome, which produces too many white blood cells in the blood and bone marrow. Gleevec works by specifically targeting cancerous cells in the bone marrow and blood, without harming healthy cells. This is in sharp contrast to traditional chemotherapy agents that kill all cells without distinction. A targeted drug approach means fewer side effects for patients, because they are able to maintain their healthy cells.

“Scientifically, Gleevec is notable for the uniqueness of the approach, that is, specifically targeting the abnormal enzyme that’s 100 percent responsible for the disease,” Dr. Schiffer said. “Personally, I’ve witnessed dramatic improvement in CML patients on Gleevec, some who had virtually no alternatives. It's incredibly gratifying.”

Prior to the approval of this drug, therapy with daily injections of interferon was the standard approach for patients with CML in its earlier, chronic phase. Dr. Schiffer says the oral drug treatment is more effective with fewer side effects than the interferon treatment.

Currently, Gleevec is approved for treating patients with three stages of CML: CML myeloid blast crisis, CML accelerated phase, and CML in chronic phase after failure of interferon treatment. High dose therapy with stem cell transplantation is the only proven therapy for CML. However it is accompanied by severe side effects and early mortality, particularly in older patients.

It is still unclear whether Gleevec cures CML or simply delays onset of more advanced forms of the cancer. Thus, patients still have to make the difficult decision between the known benefits and hazards of transplant and the unknown long-term effect from the Gleevec. Still, the FDA's accelerated approval of the drug is providing substantial relief to patients and further research is being conducted.

Dr. Schiffer joined the Barbara Ann Karmanos Cancer Institute and Wayne State University in 1997 after serving at the University of Maryland Cancer Center and the National Cancer Institute's Baltimore Cancer Research Center.

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