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
Amazon.com Inc. is launching free same-day delivery for its Prime members in Toronto and Vancouver as the busy holiday shopping season is fast approaching. Starting Tuesday, the online retailer will offer free same-day deliveries on orders over $25 of one million items in Toronto and 700,000 items in Vancouver. These items ranges from everyday household goods to toys, electronics and luggage. Nike Inc. (NKE), the world's largest athletic shoes and apparel maker, Tuesday said its first-quarter profit rose 6 percent from a year ago, driven largely by higher revenues. Shares of the company slipped over 6 percent in the after-hours trading, hurt by weak futures orders. Beaverton, Oregon-based... Germany, a clean-power trendsetter country, is planning to introduce hydrogen powered trains. The environment friendly "Coradia iLint" long distance passenger hydrails are expected to be operational by the end of 2017.
comments powered by Disqus
Follow RTT