Pfizer gets third US hematology approval in five months

US pharma giant Pfizer (NYSE: PFE) has received US Food and Drug Administration approved of its supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

The sNDA was reviewed and approved under the FDA’s Priority Review and accelerated approval programs based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial. Bosulif was first approved in September 2012 in the USA for the treatment of adult patients with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance 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, global president, Pfizer Oncology. “Today’s news marks the third FDA approval for a Pfizer hematology medicine in just five months, a significant achievement that reinforces our commitment to patients living with blood cancers,” she noted.