Tarceva approved for NSCLC
The FDA has approved OSI Pharmaceuticals' and Genentech's Tarceva (erlotinib), after priority review, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
The FDA has approved OSI Pharmaceuticals' and Genentech's Tarceva (erlotinib), after priority review, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
Tarceva is an oral tablet indicated for daily administration, and is the only drug in the epidermal growth factor receptor (EGFR) class to demonstrate in a Phase III clinical trial an increase in survival in advanced NSCLC patients. Tarceva will be available within five shipping days.
'The FDA approval of erlotinib marks an important new treatment option for patients in the United States with advanced non-small cell lung cancer after chemotherapy has failed,' said Dr Alan Sandler, associate professor of medicine at Vanderbilt University and medical director of the Thoracic Oncology Department. 'Physicians will now be able to offer patients a new therapy that has been proven to increase survival and that is different from traditional cytotoxic chemotherapy treatment.' The FDA based its approval decision for Tarceva on results from a randomised double-blind, placebo-controlled pivotal Phase III trial of patients with second and third-line advanced NSCLC.
Results from two multicentre, placebo-controlled, randomised Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin), and its use is not recommended in that setting.
'This is a significant day for non-small cell lung cancer patients and their families,' stated Dr Colin Goddard, chief executive officer of OSI Pharmaceuticals. 'Tarceva offers a new kind of therapy for advanced lung cancer patients, not only providing improved survival, but doing so without many of the side effects associated with conventional chemotherapy.'
'The FDA approval of Tarceva is the result of extraordinary effort and commitment by many employees at OSI and Genentech, clinical investigators, the FDA, and most importantly, the patients who volunteered to be part of the clinical trial that resulted in this approval,' said Dr Arthur Levinson, Genentech's chairman and chief executive officer.