ROCHE'S TARCEVA RECEIVES POSITIVE OPINION FOR PANCREATIC CANCER

Roche has announced that its oral cancer medicine Tarceva (erlotinib) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use following a reexamination of the data supporting the use of Tarceva in metastatic pancreatic cancer. Tarceva (EMEA) is the first treatment in more than a decade to have shown a significant survival benefit in pancreatic cancer patients where the five-year survival rate has been less than five percent, according to Roche.

Tarceva is approved in the U.S. and the European Union for patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one prior chemotherapy regimen. The drug has also been approved in the U.S. for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine chemotherapy.

Both the non-EU and the EU applications were based on data from the Phase III study that show that treatment with Tarceva plus gemcitabine results in significantly longer survival (22 percent) compared with gemcitabine alone. In addition, a higher percentage of patients were alive at 12 months in the group treated with Tarceva plus gemcitabine, compared with those treated with chemotherapy alone (24 percent versus 19 percent).

Tarceva (erlotinib) is a small-molecule that targets the human epidermal growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumor cell growth by inhibiting the tyrosine kinase activity of the HER1 signaling pathway inside the cell.