Pfizer's Bosulif gets conditional approval in EU

Pfizer Inc. (NYSE:PFE) said the European Commission granted conditional approval to an MAA for Bosulif bosutinib to treat adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). The drug is indicated for patients previously treated with one or more tyrosine kinase inhibitors (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. As part of the conditional approval, which is renewable annually, Pfizer must provide EMA with additional efficacy and safety data for review. The EC may convert the conditional approval to full approval.

The European conditional approval of Bosulif was based on data from the single-arm Phase I/II Study 200 trial in more than 500 patients. FDA granted full approval to the dual inhibitor of BCR-ABL and Src kinase based on the Study 200 data in September (see BioCentury Extra, Sept. 4, 2012). ...