Bosutinib for Chronic Myelogenous Leukemia

TON - September 2012 VOL 5, NO 8 — October 11, 2012

The US Food and Drug Administration (FDA) approved bosutinib tablets (Bosulif; Pfizer) for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML) who did not respond or were resistant to prior therapy.

The September 4, 2012, approval was based on the results of a single-arm, open-label, multicenter trial in 546 adults (503 evaluable for efficacy) with chronic, accelerated, or blast phase CML. All patients had been previously treated with at least 1 tyrosine kinase inhibitor (TKI).

The efficacy end points for patients with chronic phase CML were the rate of major cytogenetic response (MCyR) at week 24, and the duration of MCyR. The rate of confirmed complete hematologic response (CHR) and overall hematologic response (OHR) by week 48 were the efficacy end points for patients with accelerated or blast phase CML.

For those with chronic phase CML, 33.8% of patients who had received 1 prior TKI (imatinib) achieved MCyR at week 24 while 26.9% of patients who received prior therapy with more than 1 TKI (imatinib followed by dasatinib and/or nilotinib) achieved MCyR by week 24. Among patients with accelerated or blast phase CML who had received 1 prior TKI, 30.4% and 15%, respectively, achieved CHR response by week 48, while 55.1% and 28.3%, respectively, achieved OHR by week 48.

Diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue were the most common side effects in the safety population of patients.

Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, noted, “With the approval of tyrosine kinase inhibitors, we are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease.”

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