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Following FDA Approvals, CML Pipeline Has Challenges

Danielle Bucco
Published: Tuesday, Apr 24, 2018

Michael J. Mauro, MD

Michael J. Mauro, MD
The past year has seen the release of data regarding advances in the treatment of patients with chronic myeloid leukemia (CML), including some leading to recent regulatory approvals, but remaining challenges include conceptualizing treatment-free remission and optimal sequence of therapies.

In December 2017, the FDA approved bosutinib (Bosulif) for patients with Philadelphia chromosome-positive (Ph+) CML, based on findings from the BFORE trial. In the open-label phase III trial, the major molecular response at 12 months was 47.2% with bosutinib (95% CI, 40.9%-53.4%) compared with 36.9% (95% CI, 30.8%-43.0%) for imatinib (Gleevec; P = .02). The complete cytogenetic response rate by 12 months was 77.2% (95% CI, 72.0%-82.5%) with bosutinib versus 66.4% (95% CI, 60.4%- 72.4%) for imatinib (P = .0075).

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