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Tarceva in association with Gemzar for advanced, inoperable or metastatic pancreatic carcinoma, FDA approved

The FDA ( U.S. Food and Drug Administration ) has approved Tarceva ( Erlotinib ) in combination with Gemcitabine ( Gemzar ) chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy.

Tarceva is the first drug in a Phase III trial to have shown a significant improvement in overall survival when added to Gemcitabine chemotherapy as initial treatment for pancreatic cancer.

Tarceva is a once-daily oral tablet already approved for use in patients with non-small cell lung cancer ( NSCLC ) whose disease has progressed after one or more courses of chemotherapy.

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 ( PanCAN ).

The FDA based its approval decision for Tarceva on results from a randomized double-blind, placebo-controlled Phase III clinical study of Tarceva, in combination with Gemcitabine chemotherapy in patients with unresectable locally advanced or metastatic pancreatic cancer.

The study met its primary endpoint of improving overall survival.
Compared to Gemcitabine plus placebo, those patients receiving Gemcitabine plus Tarceva 100 mg/day demonstrated a statistically significant ( 23 percent ) improvement in overall survival ( hazard ratio = 0.81; p = 0.028 ).

After one year, 24 percent of patients receiving Tarceva plus Gemcitabine were alive compared to 19 percent of patients receiving Gemcitabine plus placebo.
A statistically significant improvement in progression-free survival ( hazard ratio = 0.76; p = 0.006 ) also was demonstrated.

Although no difference in tumor response was observed ( 8.6 percent in patients receiving Tarceva plus Gemcitabine versus 7.9 percent in the Gemcitabine plus placebo arm ), the disease control rate ( complete response + partial response + stable disease ) was significantly improved ( 59 percent in patients receiving Tarceva plus Gemcitabine versus 49 percent in the Gemcitabine plus placebo arm, p = 0.036 ).

The global study was conducted by the National Cancer Institute of Canada in collaboration with OSI Pharmaceuticals.

Tarceva has a well-established safety profile.

In the Phase III study in pancreatic cancer, the most common adverse events reported were fatigue, rash, nausea, anorexia and diarrhea.
Rash was reported in 69 percent of patients who received Erlotinib plus Gemcitabine and in 30 percent of patients who received Gemcitabine plus placebo.
Diarrhea was reported in 48 percent of patients who received Erlotinib plus Gemcitabine and in 36 percent of patients who received Gemcitabine plus placebo.

Two percent of the patients discontinued Erlotinib because of rash and 2 percent because of diarrhea.
In addition, severe and potential fatal adverse events included interstitial lung disease-like complications, myocardial infarction or ischemia, cerebrovascular accident, and microangiopathic hemolytic anemia with thrombocytopenia.

Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 ( EGFR/HER1 ) pathway, which is one of the factors critical to cell growth in a number of different cancer types.
EGFR/HER1 is a component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers.
Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth.

According to the World Health Organization, more than 216,000 people worldwide are diagnosed each year with pancreatic cancer.
The American Cancer Society predicts that in 2005 about 32,180 people in the United States will be diagnosed with pancreatic cancer and about 31,800 will die of the disease. Although pancreatic cancer accounts for 2 percent of new cancer cases in the United States, it is the fourth leading cause of all cancer deaths.
Most pancreatic tumors originate in the exocrine duct cells or in the cells that produce digestive enzymes ( acinar cells ). Called adenocarcinomas, these tumors account for nearly 95 percent of pancreatic cancers.

Source: OSI Pharmaceuticals, 2005