US and EU regulators will consider label extension for Bosulif

30 August 2017

New York’s Pfizer (NYSE: PFE) and UK-based Avillion have applied to regulators in Europe and the USA to expand the label for chronic myeloid leukemia (CML) drug Bosulif (bosutinib).

First approved in September 2012, the companies want to add new indications for the tyrosine kinase inhibitor (TKI), to cover newly-diagnosed chronic phase Philadelphia chromosome-positive CML patients.

Having granted the application priority review status, the US Food and Drug Administration is expected to provide a decision in December this year.

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