FDA Clears Bristol-Myers Leukemia Drug
A new Bristol-Myers Squibb Co. pill won U.S. approval for fighting two types of leukemia in patients running out of treatment options, the company said on Wednesday. The drug called Sprycel was shown to help some patients with chronic myeloid leukemia (CML) that had stopped responding to Novartis AG's pill Gleevec. Bristol-Myers said it expects to have the drug on the market within days. In addition to CML, the FDA approval covers treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia who have stopped responding to other treatment. Morgan Stanley analysts have projected annual Sprycel sales of $700 million by 2010, possibly rising to multibillion-dollar levels if the drug competes with Gleevec for earlier use in CML. Gleevec has delivered dramatic results putting CML into remission for up to five years, but some experts say 20 percent of patients do not respond to it or develop resistance. Before Spycel's approval, those patients had few if any options. Some could undergo a bone-marrow transplant, but the procedure is risky. About 4,600 new CML cases are diagnosed each year in the United States, according to The Leukemia & Lymphoma Society. Known generically as dasatinib, Sprycel is designed to block several proteins involved in the overproduction of abnormal white blood cells that occurs in CML. Gleevec targets a single protein that drives CML. Its generic name is imatinib.
(background: My mom died of complications resulting from a bone-marrow transplant she had to treat CML, I've been involved with fundraisig for the Leukemia Society for a couple years now)