The FDA granted accelerated approval Wednesday to Bristol-Myers Squibb Co.'s drug, Sprycel (dasatinib), as an oral inhibitor of multiple tyrosine kinases, for the treatment of adults in all phases of CML, if they have shown resistance or intolerance to prior therapy.
The FDA also granted full approval to use the drug on adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.
Dr. Charles L. Sawyers, senior author of a Sprycel trial and an investigator with the Howard Hughes Medical Institute at the University of California, Los Angeles' Jonsson Cancer Center, tells Forbes, "Gleevec [the leading drug in treating CML] is great, there's no question."
"There is a reason to have a second drug, and the second drug [Sprycel] looks good."
Bristol-Myers says Sprycel will be available nationwide, within days.
