PORTLAND, OREGON — The Food and Drug Administration approved Gleevec to treat chronic myeloid leukemia on May 10, 2001, following a 72-day review that ranked as the agency's fastest at the time. The drug inhibits an abnormal enzyme associated with the disease, shutting down uncontrolled white blood cell growth and returning patients' white blood cell counts to normal.

Chronic myeloid leukemia was one of the first cancers linked to a genetic abnormality known as the Philadelphia chromosome. People with the chromosome produce an abnormal enzyme that remains in an on position regulating cell growth. The compound imatinib, later sold under the brand name Gleevec, was discovered by biochemist Nicholas Lydon.

Brian Druker, director of the Knight Cancer Institute at Oregon Health & Science University, began testing five compounds from the company that became Novartis within six weeks of arriving at the institution. "What I saw with chemotherapy is that we were giving patients pretty toxic drugs. We didn't quite know if they'd work. And my view was there had to be a better way," Druker said.

In clinical trials, every patient who took a high dose of Gleevec responded to the treatment within six months, and side effects were generally mild. Reflecting on the drug's approval, Druker said, "I felt sort of like I was sending a child off to college and I wanted them to go out in the world and succeed and do great things for the world."

Survival curves produced during the project showed that patients on Gleevec remained alive and responded well.

Mel Mann, an Army major, was diagnosed with chronic myeloid leukemia in January 1995 at age 37. "I was shocked because that was the first time I had to face my own mortality," Mann said. He began taking imatinib in August 1998 as part of a clinical trial, and by June 1999 he ran a marathon in Anchorage, Alaska while on the drug.

Gleevec launched at $26,000 per year in 2001 and became more expensive over time. The generic version now costs a few hundred dollars per year. "There's now over 100 targeted cancer drugs on the market, which in many cases have meaningfully improved the overall survival and quality of life," said Ameet Sarpatwari, assistant professor of population medicine at Harvard Medical School.