Sprycel® Gets Full Approval for Adults with Chronic Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) has granted full approval to Bristol-Myers Squibb Company’s agent Sprycel® (dasatinib) for the treatment of adult patients in all phases of chronic myeloid leukemia (CML) who are resistant or intolerant to prior therapies including Gleevec® (imatinib mesylate).

Sprycel is an oral tyrosine kinase inhibitor reducing the activity of the BCR-ABL, SRC family, c-KIT, EPHA2, and PDGFR kinases.

Sprycel is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.