Good EMA news for Pfizer's Bosulif but not for Santhera's Raxone

Following its monthly meetings last week, the European Medicines Agency the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorization for US drugs behemoth Pfizer’s (NYSE: PFE) Bosulif (bosutinib) 100mg and 500mg film-coated tablets intended for the treatment of chronic myelogenous leukemia (CML).

Bosulif, which was approved by the US Food and Drug Administration last fall and has forecast sales of around $340 million by 2016 (The Pharma Letter September 6, 2012), was designated as an orphan medicinal product in Europe on August 4, 2010.

Bosutinib, a protein kinase inhibitor (L01XE14), acts by inhibiting the abnormal Bcr-Abl kinase that promotes CML. The benefits with Bosulif are its haematological or cytogenetic response rates in patients with CML previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. The most common side effects are diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anaemia, pyrexia and alanine aminotranserase increased, the EMA noted.