Tarceva granted FDA approval in pancreatic cancer

Tarceva is the first drug in a phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer.

The drug is a once-daily oral tablet already approved for use in patients with non-small cell lung cancer whose disease has progressed after one or more courses of chemotherapy.

Roche, OSI’s international partner for Tarceva, has submitted a marketing authorization application to the European Health Authorities for Tarceva in the new indication.

“Improvements in therapy in advanced pancreatic cancer have been very difficult to come by. As a molecularly targeted agent, erlotinib (Tarceva) has been shown to add a survival benefit when combined with gemcitabine for patients facing pancreatic cancer,” said Dr Malcolm Moore, study chair and medical oncologist at Princess Margaret Hospital in Toronto, Canada.