logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Approves Pfizer's Bosulif For Patients With Previously Treated Ph+ CML

Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration or FDA has approved Bosulif (bosutinib), an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia or CML with resistance, or intolerance to prior therapy.

The company said Patients in the registrational trial included patients who were previously treated with imatinib [Gleevec] or imatinib plus at least one second generation tyrosine kinase inhibitor or TKI. Once daily Bosulif represents the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second generation TKI.

Bosulif is a kinase inhibitor that limits cancer cell growth by inhibiting the Abl and Src signaling pathways. The recommended dose of Bosulif is 500 mg, orally, taken once daily, with food.

The company said that the most common adverse reactions observed in greater than 20 percent of the patients in the Phase 1/2 safety population (n=546) were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia and fatigue.

Pfizer said that BOSULIF may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving Bosulif.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Shares of Fitbit Inc. (FIT) slumped over 12 percent in extended hours trading after the maker of wearable technology reported a drop in first-quarter profit hurt largely by a surge in operating costs. The company also detailed a weak outlook for the second quarter. Fitbit's profit for the first-quarter... Twenty-First Century Fox Inc., (FOXA, FOX) on Wednesday reported a third-quarter profit that dropped from last year, as an increase in revenues were offset by higher operating costs. Earnings for the quarter came in line with Wall Street estimates, while revenues trumped expectations. Fox's third-quarter... Electric car maker Tesla Motors Inc. (TSLA), Wednesday reported a first-quarter loss that widened from last year, hurt largely by higher operating costs which offset an increase in revenues. Loss for the quarter were narrower than what Wall Street expected, while revenues came in line with estimates. Shares...
comments powered by Disqus
Follow RTT