Date: 2014-08-11
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Avillion (UK) Pfizer (USA - NY)
Product: Bosulif® (bosutinib)
Action
mechanism: Bosulif® (bosutinib) is an oral, once-daily tyrosine kinase inhibitor (TKI), which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. Bosulif® is currently approved in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, Bosulif® was granted conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Disease: chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML)
Therapeutic area: Cancer - Oncology - Rare diseases
Country: Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Singapore, Slovakia, Spain, Sweden, Ukraine, UK, USA
Trial
details: Avillion intends to enrol approximately 530 patients into the BFORE (Bosutinib trial in First line chrOnic myelongenous leukemia tREatment) trial at multiple sites in the United States, Asia and Europe. The trial is a Phase 3, two-arm, randomized, open label trial. Patients will be randomized 1:1 to receive bosutinib or imatinib for the duration of the study. The primary outcome is to show superiority of bosutinib over imatinib at 12 months by comparing the proportion of patients in each arm whose levels of the Bcr-Abl1 kinase, the target for bosutinib, have dropped below 0.1%. (NCT02130557)
Latest
news: * On August 11, 2014, Avillion LLP, a co-developer of late-stage pharmaceutical assets, announced that the first patients have been dosed in the United States in a global Phase 3 clinical trial called “BFORE,” which is designed to assess the effectiveness and safety of Bosulif® (bosutinib) as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). The first patient was dosed on July 22, 2014. On January 9, 2014, Avillion announced it had entered into an exclusive collaborative development agreement with Pfizer to conduct a global Phase 3 clinical trial of Bosulif®.
