U.S. FDA approves Pfizer’s Bosulif (bosutinib) for the treatment of patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML).
The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.”s 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 U.S. 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.”
The approval was based on results from BFORE, a randomized multicenter, multinational, open-label Phase 3 study which showed Bosulif 400 mg was associated with a significantly higher rate of patients achieving major molecular response (MMR) at 12 months compared to the rate achieved in patients treated with imatinib 400 mg, a current standard of care.
Pfizer and Avillion entered into an exclusive collaborative development agreement in 2014 to conduct the BFORE trial. Under the terms of the agreement, Avillion provided funding and conducted the trial to generate the clinical data used to support this application and other potential regulatory filings for marketing authorization for Bosulif as first-line treatment for patients with chronic phase Ph+ CML.
With this approval, Avillion is eligible to receive milestone payments from Pfizer. Pfizer retains all rights to commercialize Bosulif globally.
(Source: Pfizer Inc.)
Filed Under: Drug Discovery