The FDA approved today a combination therapy - Tarceva (erlotinib) and Gemzar (gemcitabine) - for treatment of chemotherapy-naive patients with advanced pancreatic cancer .

The approval makes Tarceva, an oral small-molecule inhibitor of the epidermal growth factor (EGFF), the first newly approved therapy for advanced pancreatic cancer in almost a decade. The drug is marketed in the U.S. by Genentech here and OSI Pharmaceuticals of Melville, N.Y.

Gemzar, the other half of the newly-approved combo, is the current gold standard for treatment of pancreatic cancer .

The approval had been expected since Sept. 12 when FDA advisers recommend by a 10-to-3 vote that the FDA approve the Tarceva-Gemzar combo.

The FDA analyzed data from a study of 569 patients that compared combination Tarceva-Gemzar treatment to Gemzar alone. Patients in the combination therapy arm survived an average of 12.8 days longer than those in the Gemzar monotherapy arm. In that study there were six Strokes among patients receiving Tarceva and Gemzar and no strokes in the monotherapy arm.

Testifying at the advisory panel meeting, Mace Rothenberg, M.D., an oncologist at Vanderbilt Ingram Cancer Center in Nashville, said that improvements in cancer treatment are usually incremental. But that said, Tarceva’s survival advantage is the first time in almost a decade that any drug has been shown to let pancreatic cancer patients live longer, noted Dr. Rothenberg, who argued the Tarceva case on behalf of OSI.

Worldwide more than 216,000 cases of pancreatic cancer are diagnosed each year. In the U.S., the American Cancer Society estimates that more than 32,000 Americans will be diagnosed with pancreatic cancer this year and 31,000 will die of the disease. Moreover, although pancreatic cancer is responsible for just 2% of new cancers diagnosed annually, it is the fourth leading cause of cancer death.