Bosutinib in CML Cleared for Approval in Europe

Zosia Chustecka

January 18, 2013

Bosutinib (Bosulif, Pfizer) has been recommended for approval in Europe for the treatment of chronic myelogenous leukemia (CML). The drug received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), which is a recommendation for marketing authorization.

Bosutinib was approved in the United States in September 2012.

It is the fourth tyrosine kinase inhibitor (TKI) to be approved, after the original breakthrough TKI imatinib (Gleevec, Novartis) and the second-generation TKIs nilotinib (Tasigna, Novartis Oncology) and dasatinib (Sprycel, Bristol-Myers Squibb).

The approved indication acknowledges this by stipulating that bosutinib is for patients who have previously been treated with 1 or more TKI, and for patients for whom imatinib, nilotinib, and dasatinib are not appropriate treatment options.

The most common adverse effects are diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and elevation of the liver enzyme alanine aminotransferase, according to the CHMP notice.