Pfizer said Tuesday that the U.S. Food and Drug Administration gave an early green light to use BOSULIF (bosutinib) to treat newly-diagnosed leukemia patients based on results that tout its efficacy.
BOSULIF can now be used to treat newly diagnosed patients with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The FDA first approved the drug in 2012 to treat the rare, chronic blood cancer that did not respond or were intolerant to prior therapy.
“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,” said Liz Barrett, Pfizer Oncology’s global president.
The approval came from the data that showed the drug was better than Novartis’ Gleevec (imatinib), the current standard of care.
Pfizer said its phase 3 BFORE trial showed the BOSULIF arm had a higher molecular response compared to Gleevec (47.2 percent vs. 36.9 percent). Complete cytogenic response rate at 12 months was also higher in the BOSULIF arm with 77.2 percent compared to imatinib-treated patients with 66.4 percent, the company said.
The most common side effects of BOSULIF were diarrhea (70 percent), nausea (35 percent), and thrombocytopenia (35%), among others.
Pfizer and Avillion co-developed the drug following an exclusive collaborative development agreement in 2014 to conduct the BFORE trial, the company said.
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