The committee voted ten to three to recommend the drug to be used in combination with gemcitabine in patients who have not received previous chemotherapy.
Tarceva, which is already approved to treat non-small cell lung cancer, is the first drug in a phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy in first-line pancreatic cancer.
Pancreatic cancer has the highest one-year mortality rate of any cancer. The average life expectancy for a patient diagnosed with metastatic pancreatic cancer is three to six months, according to The Pancreatic Cancer Action Network.
“We are pleased with the recommendation of the advisory committee and we look forward to the FDA’s decision on our pancreatic cancer application,” said Dr Colin Goddard, CEO of OSI Pharmaceuticals. “Tarceva is the first new potential therapy in nine years to have shown, in a randomized clinical trial, a statistically significant improvement in survival of patients suffering from advanced pancreatic cancer, a disease with a very poor prognosis for most patients.”
The FDA will now review the ODAC recommendation and a decision on Tarceva approval is anticipated by November 2, 2005.