FDA OKs New Pancreatic Cancer Treatment
Lung Cancer Drug Tarceva Cleared to Help Treat Advanced Disease
Nov. 7, 2005 -- The FDA has approved the use of the lung cancer drug Tarceva to treat advanced pancreatic cancer.
Tarceva was cleared for use in combination with Gemzar (gemcitabine), a chemotherapy drug, which is used to treat pancreatic cancer.
Pancreatic cancer is the No. 4 cause of cancer deaths in the U.S.
Tarceva's new use focuses on pancreatic cancer patients who haven't had chemotherapy before and whose disease is locally advanced or has spread to other parts of the body.
Tarceva is a pill. It's designed to block tumor cell growth. To do that, it targets a receptor on some cell surfaces called human epidermal growth factor receptor 1.
Tarceva is already used as a treatment for the most common type of lung cancer -- nonsmall cell lung cancer.
The FDA approved Tarceva for pancreatic cancer based on a study of 569 pancreatic cancer patients. The study was a phase III clinical trial -- the last type of trial required for new drug treatments by the FDA.
Half of the patients took Tarceva and Gemzar. The others took Gemzar and an empty drug (placebo). The patients didn't know whether they'd gotten Tarceva.
A year later, 24% of the Tarceva group was still alive, compared with 19% of those who didn't take Tarceva.
Rash and diarrhea were seen more often in the Tarceva group than with the placebo. Few patients quit the trial over those side effects.
More severe -- and much rarer -- side effects with Tarceva can include:
- Lung problems that resemble interstitial lung disease.
- Bleeding and clotting problems that can prompt heart attacks, strokes, and other conditions.
- Liver problems.
Women taking Tarceva should avoid becoming pregnant or breastfeeding.
Tarceva is marketed in the U.S. by OSI Pharmaceuticals and Genentech BioOncology. OSI Pharmaceuticals has licensed Roche to market Tarceva outside the U.S. Genentech and Roche are WebMD sponsors.