Conditional EU approval for Pfizer's CML drug Bosulif

The European Commission has granted conditional marketing authorization for US drugs behemoth Pfizer’s (NYSE: PFE) Bosulif (bosutinib) in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (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.

Bosulif, which was approved by the US Food and Drug Administration last fall, has forecast US sales of around $340 million by 2016 (The Pharma Letter September 6, 2012). More recently, the drug’s approval was recommended by the European Medicines Agency’s advisory panel, the Committee for Medicinal Products for Human Use (TPL January 21). Other drugs approved to treat various forms of CML include imatinib (in 2001), dasatinib (Bristol-Myers Squibb’s Sprycel in 2006) and nilotinib (Novartis’ Tasigna in 2007).

“I’m delighted the EC has approved Bosulif as a new addition to the CML treatment landscape in Europe,” said Carlo Gambacorti-Passerini, Professor of Internal Medicine at the University of Milano Bicocca in Italy, and director of the Clinical Research Unit, Section of Hematology at S Gerardo Hospital in Monza, Italy, and a lead investigator in the Bosulif clinical study quoted by Pfizer. “It’s critical to have additional treatment options for CML patients, because each patient responds to therapy differently and has unique needs. Based on my experience with Bosulif, I believe this once-daily treatment, with its distinct safety profile, offers an important new alternative,” he added.