Posted by Michael Wonder on 20 Dec 2017
U.S. FDA approves Pfizer’s Bosulif (bosutinib) for the treatment of patients with newly-diagnosed PH+ chronic myelogenous leukaemia (CML)
19 December 2017 - Pfizer's third U.S. haematology approval in five months.
Pfizer today announced the U.S. FDA approved a supplemental new drug application 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 application 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.
The approval was based on results from BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment), 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 (47.2%; 95% CI, 40.9-53.4) compared to the rate achieved in patients treated with imatinib 400 mg (36.9%; 95% CI, 30.8-43.0), a current standard of care (two-sided P=0.0200).
