US Food and Drug Administration (FDA) has approved Pfizer's Bosulf (bosutinib) to treat adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) (CML) with resistance to prior therapy.
Bosulif is a kinase inhibitor that stops the cancer cell growth by inhibiting the Abl and Src signaling pathways.
The drug is the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second generation TKI, according to the company.
Pfizer Oncology Business Unit president and general manager Garry Nicholson said Bosulif is the third new medicine from Pfizer Oncology's pipeline to be approved by the FDA in just 13 months.
"By focusing our pipeline on those compounds best positioned for advancement, we have been able to bring yet another important therapy to patients who urgently need it," Nicholson added.
Pfizer Oncology Business Unit Clinical Development and Medical Affairs vice president Mace Rothenberg said, "We believe many doctors and CML patients will find this treatment to be a welcome addition, offering a distinct adverse event profile and a convenient once-daily dosing regimen."
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