Date: 2014-12-09
Type of information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9 in San Francisco, CA
Company: 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.The drug is currently approved in the U.S. for the treatment of adult patients with Philadelphia chromosome-positive (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. The potential of Bosulif® in previously untreated patients with CML at a 400 mg dose is being investigated in the ongoing Phase 3 BFORE trial as part of a novel, co-development partnership between Pfizer and Avillion LLP.
Disease: chronic myeloid leukemia
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 9, 2014, Pfizer announced the presentation of long-term follow-up data from the Pfizer-sponsored pivotal study of Bosulif® (bosutinib) in patients with refractory chronic myeloid leukemia (CML). Research was presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco, December 6-9. These analyses demonstrated durable clinical benefit in multiple treatment settings. At five years (publication-only abstract), 41 percent of patients with chronic phase (CP) CML in the second-line setting (n=284) remained on treatment, and importantly, at four years (abstract #4559), 24 percent of patients receiving Bosulif® as third-line therapy (n=119) remained on treatment. Treatment emergent adverse events (TEAEs) in the five- and four-year data were consistent with the known safety profile of Bosulif®. In the five-year analysis, the most common grade 3 and/or 4 TEAEs for second-line CP CML patients included diarrhea (10 percent), nausea (1 percent), vomiting (4 percent), rash (9 percent) and thrombocytopenia (26 percent). In the four-year analysis, the most common grade 3 and/or 4 TEAEs for third-line CP CML patients included diarrhea (9 percent), nausea (1 percent), vomiting (1 percent), rash (3 percent), headache (3 percent), abdominal pain (1 percent), fatigue (2 percent), thrombocytopenia (26 percent), neutropenia (16 percent) and anemia (7 percent).
