This article is more than 5 years old. Information may no longer be current.
FDA expands approval of Bosulif for chronic myelogenous leukemia
Click Here to Manage Email Alerts
The FDA expanded the approval of bosutinib to include adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.
Bosutinib (Bosulif, Pfizer) — an oral, once-daily tyrosine kinase inhibitor — already had been approved to treated adults with Ph+CML who were resistant to or intolerant of prior therapy.
The FDA based the expanded approval on results of the multinational, open-label, randomized phase 3 BFORE trial, which included 536 patients with chronic phase Ph+CML. Researchers assigned patients 1:1 to bosutinib 400 mg or imatinib 400 mg.
A higher percentage of patients assigned bosutinib achieved major molecular response at 12 months (47.2% vs. 36.9%).
Results also showed a significantly higher rate of complete cytogenic response at 12 months in the bosutinib group (77.2% vs. 66.4%).
The adverse events observed in the trial were consistent with the known safety profile of bosutinib. The most common adverse events included diarrhea (70%), nausea (35%), thrombocytopenia (35%), rash (34%), increased alanine aminotransferase (31%), abdominal pain (25%) and increased aspartate aminotransferase (23%).
“Bosulif was Pfizer’s first treatment for hematologic malignancies, and has since become an important treatment option for Ph+ CML patients who are resistant or intolerant to previous therapy. This expanded indication has the potential to make an even greater impact on the lives of patients with CML,” Liz Barrett, global president of Pfizer Oncology, said in a company-issued press release. “[This] marks the third FDA approval for a Pfizer hematology medicine in just 5 months, a significant achievement that reinforces our commitment to patients living with blood cancers.”