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Bosutinib Nears EU Approval for Frontline Ph+ CML

Jason M. Broderick @jasoncology
Published: Monday, Feb 26, 2018

Dr. Mace Rothenberg

Mace Rothenberg, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of bosutinib (Bosulif) as a first-line treatment for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), according to Pfizer, the developer of the third-generation tyrosine kinase inhibitor. 

All-grade diarrhea (70% vs 34%) and grade ≥3 diarrhea (8% vs 1%) were significantly higher with bosutinib versus imatinib. Patients in the experimental arm were also much more likely to experience all-grade liver toxicity (40% vs 14%) and grade ≥3 liver toxicity (24% vs 4%). The most common treatment-emergent AEs (TEAEs) of any grade with bosutinib were diarrhea (70.1%), nausea (35.1%), thrombocytopenia (35.1%), increased ALT (30.6%), and increased AST (22.8%). Grade ≥3 TEAEs occurred in 56.3% of patients receiving bosutinib, most commonly ALT increase (19.0%) and thrombocytopenia (13.8%). 
Cortes JE, Gambacorti-Passerini C, Deininger MWN, et al. Bosutinib (BOS) versus imatinib (IM) for newly diagnosed chronic myeloid leukemia (CML): Initial results from the BFORE trial. J Clin Oncol. 2017;35 (suppl; abstr 7002).

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