FDA Approves Bosutinib for Newly Diagnosed Chronic Myeloid Leukemia
Approval was based on results from the randomized phase 3 BFORE trial, which showed a higher MMR rate in patients treated with bosutinib than in those treated with imatinib.
The US Food and Drug Administration approved bosutinib, a second-generation tyrosine kinase inhibitor (TKI), for patients with newly diagnosed, Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase, according to a press release.1
Approval was based on results from the randomized phase 3 BFORE trial (ClinicalTrials.gov Identifier: NCT02130557), which showed a higher major molecular response (MMR) rate in patients treated with bosutinib (12-month MMR rate, 47.2%) than in those treated with imatinib (12-month MMR rate, 36.9%; P = .02), the standard first-line treatment for CML.
While imatinib can be a highly effective treatment for patients with CML, resistance or refractory disease is a serious concern, which led to the need for second-generation TKIs. BFORE suggests, however, that patients with CML are likely to have deep molecular responses with bosutinib in the first line.
Common adverse events (AEs) noted with bosutinib include “diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.”
Grade 3 to 4 AEs were, however, more common in the bosutinib arm.
- FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML [news release]. Silver Spring, MD: US Food and Drug Administration; December 19, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm589856.htm. Accessed December 20, 2017.