HealthDay News — The FDA has approved bosutinib (Bosulif, Pfizer) to treat chronic myelogenous leukemia (CML).
Bosutinib is indicated for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML, who are resistant to or who cannot tolerate other therapies, including imatinib. The drug works by blocking the tyrosine kinase signal that promotes abnormal, unhealthy granulocyte development, the FDA said in a press release.
Bosutinib was evaluated in a clinical trial that included 546 adults with CML, whose illness progressed after treatment with other FDA sanctioned medications, including imatinib or imatinib followed by dasatinib and/or nilotinib, or who discontinued therapy due to adverse events.
Among patients with accelerated CML, who were previously treated with at least imatinib, 33% had their blood counts return to normal range (complete hematologic response) and 55% achieved normal blood counts with no evidence of leukemia (overall hematologic response) within the first 48 weeks of treatment with bosutinib. Among those with blast phase CML, 15% and 28% achieved complete hematologic response and overall hematologic response, respectively.
The drug’s most common side effects included diarrhea, nausea, thrombocytopenia, abdominal pain, rash, anemia, fever, and fatigue.