FDA Approves First New Therapy In a Decade For Most Lethal Cancer

Armen Hareyan's picture

Pancreas Cancer Therapy

The U.S. Food and Drug Administration has approved the first new therapy in almost a decade for pancreas cancer, the fourth leading cause of cancer death in the United States.


The FDA approved the addition of the targeted agent erlotinib (marketed as Tarceva) to the chemotherapy drug gemcitabine, which has been the only approved therapy for advanced pancreas cancer since its approval in 1996. The approval of Tarceva was based on a study demonstrating the combination increased overall survival by 23 percent and "progression-free survival" by 30 percent over treatment with gemcitabine alone.

These improvements were both statistically significant and clinically meaningful and were made without sacrificing overall "quality of life" due to side effects, said Mace L. Rothenberg, M.D., Ingram Professor of Cancer Research and director of Phase I Drug Development at the Vanderbilt-Ingram Cancer Center.

"Tarceva plus gemcitabine is an important treatment option for patients and physicians who want a more aggressive, more effective treatment for advanced pancreas