NEW YORK – The US Food and Drug Administration on Tuesday approved Pfizer's tyrosine kinase inhibitor Bosulif (bosutinib) as a treatment for children with chronic phase, Philadelphia chromosome (Ph)-positive chronic myelogenous leukemia (CML).
The approval makes Bosulif available to pediatric patients with both newly diagnosed and previously treated Ph-positive CML.
The FDA approved Bosulif based on data from the Phase I/II BCHILD clinical trial, in which 28 patients with treatment-resistant or intolerant disease and 21 patients with newly diagnosed disease received the drug. To be eligible for the trial, patients had to have Ph-positive CML established via cytogenic and molecular testing at initial diagnosis or during study screening.
Among the previously treated group, 82.1 percent of patients had a major cytogenetic response; 78.6 percent had a complete cytogenetic response; and 50 percent had a major molecular response. Among the newly diagnosed group, 76.2 percent had a major cytogenetic response; 71.4 percent had a complete cytogenic response; and 28.6 percent had a major molecular response.
Bosulif is also approved in the US for adults with accelerated or blast-phase, Ph-positive CML who are resistant or intolerant to prior therapy.