Bristol's leukemia drug gets FDA approval
FDA gives green light to Sprycel, second-chance treatment for cancer patients.
By Aaron Smith, staff writer

NEW YORK ( -- The FDA approved a new leukemia drug from the Bristol-Myers Squibb, the company said.

Bristol-Myers' (up $0.24 to $25.49, Charts) Sprycel received the green light from the Food and Drug Administration as a drug for two types of leukemia - chronic myeloid and acute lymphoblastic - that affect blood cells and bone marrow. The drug would be used by patients who have failed other types of treatment.


Most of the intended patients for Sprycel, an oral treatment also known as dasatinib, have already tried Novartis' (up $0.42 to $52.43, Charts) Gleevec without success. Gleevec is considered a "first-line" drug treatment for leukemia patients, while Sprycel is considered a "second-line," or second chance.

New Jersey-based Bristol-Myers is also testing the drug for a wide variety of anti-tumor treatments, including cancer of the intestinal tract, ovaries, pancreas, prostate and breasts. The company's success, or lack of success, in receiving regulatory approval for additional diseases will determine the size of its future sales.

Analyst projections for Sprycel revenues vary, ranging from $300 million to $700 million in annual sales. Analysts believe that sales could also be driven by "off-label" prescribing for treatments that have not been approved by the FDA, but have been shown to work in testing.

The Swiss drug giant Novartis will continue to reap the lion's share of sales as a first-line leukemia treatment. Gleevec is Novartis' biggest seller, with $2.2 billion in 2005 sales, and costing patients $40,000 a year.

The FDA has been busy with drug reviews this week. On Tuesday, the agency sent the drugmaker Wyeth (up $0.13 to $43.17, Charts) a letter saying that it needed to do more work on the experimental birth control drug Lybrel before it could be approved. On Friday, the agency will announce its decision on whether to approve Lucentis, an experimental drug from the biotech Genentech (up $1.27 to $79.24, Charts) that would treat the wet form of age-related macular degeneration, a type of vision loss.

Related: Little cancer drug, big ambition Top of page

Follow the news that matters to you. Create your own alert to be notified on topics you're interested in.

Or, visit Popular Alerts for suggestions.
Manage alerts | What is this?