FDA Receives Data on OHSU-Developed Leukemia Pill

03/02/01    Portland, Ore.

Fast track means approval may come as early as this summer

Novartis Oncology has submitted applications with the Food and Drug Administration, as well as health authorities around the world, for approval of Glivec (formerly STI571), a pill to fight chronic myelogenous leukemia (CML). The pill was developed by Novartis in collaboration with Oregon Health Sciences University researcher Brian Druker, M.D.

Based on promising, early study results, the FDA has designated Glivec fast-track status during development for the myeloid blast crisis phase indication of CML. Typically, such designations are given to drugs with potential to address unmet medical needs or improve upon available therapy for the treatment of a serious or life-threatening condition. In addition, Glivec was granted Orphan Drug designation by the United States, European Union and Japan, meaning those patients with advanced stages of the disease could get access to the drug even before approval.

The application comes fewer than three years after the initiation of clinical trials at OHSU, ahead of an industry average of nearly five years. The filing is based on study results from approximately 1,230 patients in 32 centers located in five countries. To date, Glivec has been studied in more than 5,000 patients in 30 countries.

"The development of Glivec has been a tremendous experience for the investigator community," said Druker, a professor of medicine and director of the Leukemia Program 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, but has allowed us to evaluate a drug that may be the first of many that may radically change how cancer is treated."

Glivec molecularly targets a protein produced by the specific chromosomal abnormality called the Philadelphia chromosome, which is present in a majority of patients with CML. Druker has worked with Novartis researchers on this drug since 1993 and began the first human clinical trials in June 1998.

At a scientific conference in December 2000, Druker and colleagues presented information showing that better than 90 percent of chronic-phase CML patients taking Glivec had their white blood cell counts return to normal, and more than a third of those patients were completely free of the Philadelphia chromosome.

"We believe that Glivec marks the beginning of a new stage in cancer therapeutics development," said David Parkinson, M.D., vice president, clinical research, Novartis Oncology. "By understanding the molecular abnormality causing the cancer -- CML in this case -- we can design drugs like Glivec that target the fundamental biochemical abnormalities associated with cancers, with better treatment results and fewer toxic effects on normal cells."

Patients and physicians interested in more information on these studies can contact the Leukemia Program at OHSU, 503 494-1117, or the Novartis Oncology Clinical Trials Hotline at 800 340-6843.