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Tarceva approved for smokers, updates labeling on hepatic failure

Executive Summary

OSI/Genentech's Tarceva (erlotinib) is now indicated for non-small cell lung cancer patients who currently smoke cigarettes, following a Sept. 19 approval. FDA reports that "the submitted data, together with previous findings, indicate that smoking reduces erlotinib exposure in both cancer patients and healthy volunteers." The agency notes that the optimal dose adjustment to compensate for this alteration is not known. Labeling is also updated Sept. 23 after cases of hepatic failure and hepatorenal syndrome, including fatalities, were reported. New data are added from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden, along with statements in Warnings and Dosage and Administration sections



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