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The Oregonian
A pill that appears to eradicate chronic myelogenous leukemia is on the fast track for U.S. Food and Drug Administration approval.
Novartis Oncology applied for approval of the pill Wednesday and expects approval to come as early as this summer, according to researchers.
"It usually takes five years before applications to market a drug are ready to be submitted to FDA, but results were so promising that the process was sped up to meet the needs of patients who had used up conventional therapies."
It usually takes five years before applications to market a drug are ready to be submitted to FDA, but results were so promising that the process was sped up to meet the needs of patients who had used up conventional therapies.
The pill, Glivec (formerly known as ST1571) was developed by Novartis in collaboration with Dr. Brian Druker, a researcher at Oregon Health Sciences University.
The application, with study results from about 1,230 patients in 32 medical centers in five countries, comes fewer than three years after the first trial was initiated at OHSU.
"Glivec has offered us not just an opportunity to provide a drug to patients that has truly changed the course of their lives," Druker said. "It allows us to evaluate a drug that may be the first of many that may radically change how cancer is treated." He is a professor of medicine and director of the leukemia program at OHSU.
Chronic myelogenous leukemia is characterized by an excessive growth of white blood cells caused by a chromosomal defect. The typical patient is about 50 or 60 years old when diagnosed.
Unlike chemotherapy, which kills normal and abnormal cells, Glivec produces dramatic results with minimal side effects. Instead of a shotgun approach, it only targets a protein produced by a specific chromosomal abnormality that is present in a majority of patients with CML.
Last December, Druker and his colleagues reported that more than 90 percent of patients who took the pill in the chronic phase of the disease had their blood cell counts return to normal, and more than a third of them were completely free of the abnormal chromosome.
Based on promising early studies, the FDA designated Glivec fast-track orphan drug designation, which means that patients in advanced stages of the disease could have access to the drug before FDA approval.
Patients and doctors interested in more information should contact the leukemia program at OHSU at 503-494-1117; or Novartis Oncology clinical trial hot line at 800-340-6843. You
Source: The Oregonian
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