said U.S. regulators granted approval for Sprycel for two different types of leukemia, a cancer of the bone marrow and blood.
Sprycel received accelerated clearance from the Food and Drug Administration for treating patients with chronic myeloid leukemia when the condition was resistant to a prior treatment or when another option, including Gleevec from
, couldn't be tolerated.
The FDA's accelerated approval program makes products for serious or life-threatening diseases available earlier in the development process based on the promising effects of the drug. However, in these cases, companies are required to conduct additional studies to verify that their product does in fact benefit patients.
The agency also granted full clearance of Sprycel for use against what's called Philadelphia chromosome-positive acute lymphoblastic leukemia, in cases where a previous therapy failed or couldn't be taken by the patient. Bristol-Myers expects Sprycel to be available within days nationwide.
Shares of Bristol-Myers rose 5 cents to $25.30 in after-hours trading Wednesday.
Leukemia is a disease marked by the uncontrolled accumulation of blood cells. The condition is broadly designated as myelogenous or lymphocytic, each of which can be acute or chronic.