Pfizer said Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion regarding conditional approval of Bosulif (bosutinib) for certain adults with chronic myelogenous leukaemia (CML).
The committee specifically backed the drug for use in patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive (Ph+) CML previously treated with one or more tyrosine kinase inhibitors and for whom Novartis' Glivec (imatinib) and Tasigna (nilotinib), as well as Bristol-Myers Squibb’s Sprycel (dasatinib), are not considered appropriate treatment options. The CHMP's recommendation was based on findings from a Phase I/II study of more than 500 patients with Ph+ CML who were previously treated with at least one tyrosine kinase inhibitor.
Pfizer's oral, once-daily, kinase inhibitor was approved in September by the FDA for use in patients with Ph+ CML.
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