CHMP recommends approval of bosutinib (Bosulif®) for CML

Source: European Medicines Agency Area: News The Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a conditional marketing authorisation for the orphan medicine bosutinib (Bosulif®) for the treatment of adults with Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. Bosutinib is a protein kinase inhibitor that acts by inhibiting the abnormal Bcr-Abl kinase that promotes CML.   The positive opinion was based on data from an open-label, single-arm Phase 1/2 study which included over 500 patients with Ph+ CML, with separate cohorts for chronic, accelerated and blast phase disease previously treated with one or more prior TKIs. The summary of opinion notes that the benefits associated with bosutinib are its haematological or cytogenetic response rates in this population (no details reported). On the ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news