NICE rebuffs Bosulif for CML

The U.K.'s NICE issued a preliminary appraisal recommending against the use of Bosulif bosutinib from Pfizer Inc. (NYSE:PFE) to treat previously treated chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) -- its approved indication. NICE said data from the single-arm Phase I/II Study 200 in more than 500 patients showed an "unclear" overall survival (OS) benefit. NICE estimated Bosulif's incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) would be at least L43,000-L89,000 ($64,943-$134,417), depending on the specific patient population. Comments are due Aug. 5.

In March, the European Commission granted conditional approval for Bosulif for Ph+ CML patients previously treated with one or more tyrosine kinase inhibitors (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. FDA granted full approval to the dual inhibitor of BCR-ABL and Src kinase in September (see BioCentury Extra, March 28). ...