Swiss drugmaker Roche’s successful lung cancer drug Tarceva (erlotinib) has now been given a green light by the US Food and Drug Administration for the treatment of pancreatic cancer, after a series of clinical studies demonstrated a significant survival benefit with use of the agent.

Currently representing the only epidermal growth factor receptor (EGFR) inhibitor to have shown a survival benefit in lung cancer, Tarceva also marks the first new therapy in a decade to induce a significant improvement in overall survival (23%) when added to chemotherapy, the group said. "Pancreatic cancer is a devastating disease, and with Tarceva patients will receive a treatment which offers survival benefits," noted William Burns, chief executive of Roche Pharma.

The new use should certainly boost Tarceva’s sales, as the market potential for an effective pancreatic cancer treatment is substantial.

"Improvements in therapy in advanced pancreatic cancer have been very difficult to come by,” commented Dr Malcolm Moore, study chair and medical oncologist at Princess Margaret Hospital in Toronto, Canada. "Erlotinib represents a notable step forward for patients and healthcare providers in a disease with a very poor prognosis," he concluded.

Meanwhile, Roche said yesterday that its oral anticancer drug Xeloda (capecitabine) has become the first drug to show extended survival in patients with inoperable pancreatic cancer patients when added to standard therapy for the disease.

According to Phase III data presented at the European Cancer Conference (ECCO) held in Paris, when Roche's drug was added to a regimen based on Eli Lilly's Gemzar (gemcitabine), 25% of the Xeloda combination group was still alive after one year versus 20% of those on Gemzar alone. The GEMCAP study involved 533 patients.

Pancreatic cancer is the fifth leading cause of malignancy-related deaths in the developed world. The disease has a poor prognosis, with most patients dying within six months of diagnosis because symptoms often do not appear until the cancer is very advanced. UK data suggest that only 13% of patients diagnosed with pancreatic cancer currently survives for a year: this was raised to 18% with gemcitabine and 26% for the combination.

"These data are very exciting and give new hope for pancreatic cancer sufferers who in general have a very short life expectancy," said Prof John Neoptolemos, surgical oncologist at the Royal Liverpool University Hospital in the UK.

- Also presented at the conference were data on Xelox, a combination of Xeloda and oxaliplatin, which showed that it was as safe as standard therapy I patients with colorectal cancer and reduced the number of hospital visits more than 60% compared to intravenous 5-fluorouracil/leucovorin.