New Warnings Added to Erlotinib Labeling

Kate Traynor

BETHESDA, MD 23 September 2008—The labeling for erlotinib has been updated to warn that patients with liver impairment should be monitored closely while receiving the drug and that treatment should be interrupted or halted in patients with severe liver impairment.

Erlotinib, which is marketed as Tarceva by OSI Pharmaceuticals Inc. and Genentech Inc., is indicated for the treatment of certain patients with non-small-cell lung cancer or pancreatic cancer.

A Dear Healthcare Professional letter from the companies, dated September 2008, said two patients who were initially thought to have mild liver disease died during or within 30 days after treatment with the drug and were discovered to have had severe liver disease. The determination of mild disease, the initial diagnosis, was made using the Child-Pugh liver-disease classification scale.

The patients were participants in a pharmacokinetics study. In all, 10 of 15 study participants, all of whom had advanced cancer, died during or within 30 days after receiving erlotinib therapy. Eight of the deaths were caused by "progressive disease," according to the letter. But 6 of those who died had a baseline bilirubin level that suggested they had severe liver disease, not mild impairment, at the start of the study.

The letter notes that the bilirubin data underscore "the limitations of utilizing the Child-Pugh criteria" in patients with cancer.

The revised labeling warns that "extra caution" is needed when erlotinib is used in patients with a bilirubin level greater than 3 times the upper limit of the normal range.