Pfizer’s Bosutinib Receives Positive Opinion For Conditional Marketing Authorization From The Committee For Medicinal Products For Human Use For The Treatment Of Ph+ Chronic Myelogenous Leukemia With Resistance Or Intolerance To Prior Therapy In Europe
Drug Interactions: Avoid concurrent use with strong or moderate CYP3A inhibitors or inducers.
Proton Pump Inhibitors (PPIs): Consider using short-acting antacids or H2 blockers instead of PPIs. Separate antacid or H2 blocker dosing and BOSULIF dosing by more than 2 hours.
Substrates of P-glycoprotein: BOSULIF may increase the plasma concentrations of drugs that are P-gp substrates, such as digoxin.
Nursing Mothers: Given the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or BOSULIF.Hepatic Impairment: Treat with a dose of 200 mg daily in patients with any baseline hepatic impairment. For more information and full prescribing information, please visit www.BOSULIF.com. About Pfizer Oncology Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Hematologic cancers are a complex group of diseases, with over 70 different types of lymphomas, leukemias or myelomas. While there have been significant advancements in the treatment of some hematologic cancers, there continues to be a need for additional therapeutic options. Pfizer Oncology is committed to improving outcomes for patients living with hematologic malignancies like CML. Pfizer Oncology has a robust hematology pipeline, with biologics and small molecules in clinical development across a number of hematologic malignancies. We are advancing technologies as well as working to identify new and innovative options that address specific hematologic cancers, molecular subtypes, gene over-expression and mechanisms of resistance. For more information, please visit www.Pfizer.com. DISCLOSURE NOTICE: The information contained in this release is as of January 18, 2013. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information that involves substantial risks and uncertainties about an oncology product candidate, bosutinib, including its potential benefits, that is under review by regulatory authorities in the EU and various other jurisdictions. Such risks and uncertainties include, among other things, whether and when the European Commission and regulatory authorities in such other jurisdictions will approve drug applications that have been or may be filed for bosutinib as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K. 1 Jabbour E et al. Targeted Therapy in Chronic Myeloid Leukemia. Expert Review of Anticancer Therapy. 2008; 8: 99-110. 2 Steegman J.L et al. Off-target effects of BCR-ABL1 inhibitors and their potential long-term implications in patients with chronic myeloid leukemia. Leukemia & Lymphoma. 2012; Early Online: 1-11. 3 Cortes J, Kantarjian H. Resistance in Chronic Myeloid Leukemia: Still an Issue? American Society of Clinical Oncology. 2011; 270-274. 4 Konig H. Effects of Dasatinib on Src Kinase Activity and Downstream Intracellular Signaling in Primitive Chronic Myelogenous Leukemia Hematopoietic Cells. Cancer Research. 2008; 68: 9624-9633.
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