Cancer Drug Tarceva Linked to Kidney and Liver Problems

OSI Pharmaceuticals and Genentech, makers of Tarceva, said in a letter sent to physicians that the new safety information comes from a pharmacokinetic study in patients with advanced solid tumors and moderate hepatic impairment, as measured by Child-Pugh criteria.

In the study, 10 of 15 patients died on treatment or within 30 days of the last erlotinib dose.

Eight of the patients died of progressive disease, but the deaths from hepatorenal syndrome and rapidly progressing liver disease prompted today's notice.

Erlotinib is approved for monotherapy of locally advanced or metastatic non-small-cell lung cancer. It is also approved in combination with gemcitabine (Gemzar) for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer.

Read more about this at MedWatch