BOSULIF is a kinase inhibitor indicated for the treatment of...pediatric patients 1 year of age and older with chronic phase Ph+ (≥20%) in adult and pediatric patients are creatinine increased, hemoglobin chronic myelogenous leukemia (CML), newly-diagnosed or resistant or decreased, lymphocyte count decreased, platelets decreased, ALT intolerant to prior therapy.

Bosulif is indicated for the treatment of adult patients with:...newly‑diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML)....CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with...Newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML)….Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

...536 patients with newly diagnosed BCR-ABL1-positive CP-CML...MMR rate at 12 months was 41.0% for bosutinib versus 32.7% for imatinib...The efficacy and safety outcomes in this US subpopulation from BFORE were generally consistent with the overall study population at 5 years...These results confirm the use of bosutinib as a standard of care in patients with newly diagnosed CP-CML.

...pts diagnosed with Ph+ CML-CP who were initiated on a 2G TKI (dasatinib, nilotinib, or bosutinib) as 2L therapy...In 2L TKI therapy, 41% of pts received nilotinib, 19% dasatinib, and 40% bosutinib...Although 2G TKIs have higher efficacy and lower progression rates in 1L vs 1G TKI, a substantial proportion of pts still do not achieve the important treatment response milestones; almost 50% did not achieve MMR within 12 months of 2L TKI therapy.

A greater proportion of patients in the bosutinib versus imatinib group had BCR-ABL1 transcripts ≤ 10% at 3 months (75.2% v 57.3%) and had achieved deeper molecular responses at months 3, 6, 9, and 12 (Fig 1). Rate of CCyR by 12 months was significantly higher for patients receiving bosutinib versus imatinib (77.2% v 66.4%; P = .0075). The cumulative incidence function of CCyR was also more favorable in the bosutinib group (hazard ratio, 1.38 [95% CI, 1.13 to 1.69]; Gray’s test P < .001; Data Supplement).

Patients with CML resistant/intolerant to previous tyrosine kinase inhibitor therapy received bosutinib 500 mg once daily....156 had Ph+ CP CML...In evaluable patients with Ph+ CP CML, 81.1% (95% CI: 73.7–87.2), 71.8% (95% CI: 63.9–78.9), 59.7% (95% CI: 51.4–67.7) and 48.3% (95% CI: 40.1−56.6) attained or maintained complete cytogenetic response, major molecular response...No patients with Ph+ CP CML progressed to accelerated/blast phase on-treatment.... After 3 years, bosutinib continued to show efficacy in previously treated patients with Ph+ CP CML.

In the open-label BFORE trial (NCT02130557), 536 pts with newly diagnosed CP CML were randomized 1:1 to receive BOS (n=268) or IMA (n=268; 3 untreated), both at 400 mg once daily... Among evaluable pts, more pts in the BOS arm achieved BCR-ABL1 ≤10% at 3 months (Table); cumulative MMR by 60 mo was higher in pts with transcripts ≤10% vs >10% in both treatment arms (BOS, HR 2.67 [95% CI, 1.90–3.75]; IMA, HR 3.12 [2.19–4.45]). Pts in the BOS arm achieved responses earlier than pts in the IMA arm...These results confirm the use of BOS as a standard of care in pts with newly diagnosed CP CML.

The current analysis included 118 patients with chronic-phase CML who had been pretreated with imatinib followed by dasatinib and/or nilotinib, with a median follow-up of 28.5 months...Kaplan-Meier estimates of PFS and overall survival at 2 years were both high (73% and 83%, respectively)....Responses were seen across Bcr-Abl mutations, including those associated with dasatinib and nilotinib resistance, except T315I....Bosutinib demonstrated clinical activity and an acceptable safety profile in this study subpopulation of patients with CP CML who were previously treated with imatinib and dasatinib and/or nilotinib.