Breast-feeding: It is not known whether XALKORI and its metabolites are excreted in human milk. Because of the potential harm to the infant, mothers should be advised to avoid breast-feeding while receiving XALKORI.
Hepatic Impairment: XALKORI has not been studied in patients with hepatic impairment. Treatment with XALKORI should be used with caution in patients with mild and moderate hepatic impairment. XALKORI should not be used in patients with severe hepatic impairment.
Renal Impairment: No starting dose adjustment is recommended for patients with mild and moderate renal impairment. No data are available for patients with severe and end-stage renal disease. Therefore, no formal dosing recommendation can be made.
About Pfizer OncologyPfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. For more information please visit www.Pfizer.com. DISCLOSURE NOTICE: The information contained in this release is as of October 24, 2012. 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, XALKORI. Such risks and uncertainties include, among other things, whether and when the European Commission (EC) will convert the conditional marketing authorization to a normal marketing authorization in the EU, as well as the EC’s decisions regarding labeling and other matters that could affect XALKORI’s availability or commercial potential in the EU; whether and when regulatory authorities in various other jurisdictions in which applications for XALKORI have been filed will approve such applications, as well as their decisions regarding labeling and other matters that could affect XALKORI’s availability or commercial potential in such jurisdictions; 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.
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4 XALKORI Summary of Product Characteristics (SmPC) for the European Union.