The US Food and Drug Administration (FDA) has approved Bosulif (bosutinib) to treat adults with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

Indications: Bosulif is a kinase inhibitor indicated for the treatment of adult patients with newly-diagnosed chronic phase Ph+ CML.

Dosage and administration: 400 mg orally once daily with food.

Efficacy and safety: Approval is based on results of an open-label phase 3 study that showed Bosulif 400 mg was linked with a significantly higher rate of patients achieving major molecular response at 12 months vs the rate achieved with imatinib 400 mg (47% vs 37%). Complete cytogenic response was 77% and 66%, respectively.

Side effects/risks: The most common adverse reactions are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.