Dasatinib 20mg, 50mg, 70mg, 80mg, 100mg, 140mg; tabs.
The FDA has notified healthcare professionals that Sprycel (dasatinib; Bristol-Myers Squibb) may increase the risk of pulmonary arterial hypertension (PAH).
Bristol-Myers Squibb announced that the FDA granted accelerated approval to Sprycel (dasatinib) for the first-line treatment of Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML).
The labeling for Sprycel (dasatinib; Bristol-Myers Squibb and Otsuka) has been updated with new three-year efficacy and safety data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase and five-year data in CP Ph+ CML patients who are resistant or intolerant to Gleevec (imatinib mesylate; Novartis).
Drugs in the Pipeline
Bristol-Myers Squibb and Otsuka announced that the supplemental New Drug Application (sNDA) for Sprycel (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase has been accepted for filing and granted priority review by the FDA.
The expanded approval was supported by data from the Phase 2 multicenter, single-arm CA180-372 study (NCT01460160) which included 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL.
Drugs in the Pipeline
The sBLA contains data from the Phase 2 CA180-372 trial evaluating Sprycel as an add-on to chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
Bristol-Myers Squibb and Otsuka announced that the Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) labeling to include long-term efficacy data.
The FDA has granted full approval for Sprycel (dasatinib tablets, from Bristol-Myers Squibb), an oral tyrosine kinase inhibitor, for the treatment of adults in all phases of chronic myeloid leukemia (CML) (ie, chronic, accelerated, myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy, including Gleevec (imatinib mesylate, from Novartis).
Second-generation tyrosine kinase inhibitor approved for children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.