FDA Approves New Drug Combination For Pancreatic Cancer

FDA approved the combination of a new drug Tarceva (erlotinib and Gemzar (gemcitabine) as first-line treatment of patients with locally advanced, surgically unresectable or metastatic pancreas cancer who had not already undergone chemotherapy treatment. Gemzar alone has been the most usually used treatment in this situation .

Tarceva is currently FDA approved for the treatment of lung cancer. It is the first drug to be approved in almost a decade for advanced pancreas cancer. The treatment with Tarceva and Gemzar was shown to improve survival in previous clinical trials.

In the trial, scientists from the National Cancer Institute of Canada gave 569 patients with advanced pancreas cancer either the combination therapy or Gemzar alone. At the end of a year, 24% of the patients receiving both Gemzar and Tarceva were alive, compared to 17% of the group receiving Gemzar alone.

The progression-free survival (the time before the cancer started growing again) for those treated with the combination therapy was 3.75 months, or 6 days longer than for the pancreas cancer patients who received Gemzar alone. The median overall survival for the Tarceva/Gemzar group was 6.4 months, about 2 weeks longer than those receiving Gemzar only.

The most common side effects of Tarceva are rash and diarrhea, but the drug has also been linked to infrequent cases of a serious lung disorder.

Pancreas cancer is very difficult to treat. Each year, about 32,000 Americans are diagnosed with pancreas cancer, and about the same number will die of the disease. Pancreas cancer is responsible for only about 2% of newly diagnosed cancers in this country, but it is the fourth-leading cause of cancer death.

The high date rate is due in part to the aggressive nature of the disease as well as the difficulty in diagnosing it early enough to treat. Symptoms don't commonly appear until the disease is well-progressed. Patients could die within months of diagnosis.

Did you know?
FDA approved the combination of a new drug Tarceva (erlotinib and Gemzar (gemcitabine) as first-line treatment of patients with locally advanced, surgically unresectable or metastatic pancreas cancer who had not already undergone chemotherapy treatment. Gemzar alone has been the most usually used treatment in this situation .