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FDA Approves Bosutinib for Newly-Diagnosed Ph+ CML

Silas Inman @silasinman
Published: Tuesday, Dec 19, 2017

Jorge Cortes, MD

Jorge Cortes, MD
The FDA has granted an accelerated approval to bosutinib (Bosulif) as a first-line treatment for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), based on findings from the phase III BFORE trial.

Bosutinib was initially approved in the United States for the treatment of adult patients with Ph+ CML who have resistance or intolerance to prior therapy in September 2012. The frontline approval was granted under the FDA's accelerated approval program. Continued approval is contingent upon findings from long-term follow up.
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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