Tarceva gets CHMP OK for pancreatic cancer

Swiss drug major Roche says that its drug Tarceva (erlotinib) has received a positive approval recommendation from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use, following a re-examination of data from trials of the agent in metastatic pancreatic cancer. Specifically, the recommendation is for clearance of the product in combination with gemcitabine-based chemotherapy, which was originally the subject of a negative CHMP opinion when the data was initially examined (Marketletter August 7, 2006).

Roche added that the product, which has already been approved by the US Food and Drug Administration for this indication (Marketletter September 19, 2005), is the first treatment in over a decade to show a significant survival benefit in patients with this devastating form of cancer.

The data, which are from a Phase III study of the combined regimen, demonstrated that treatment brought about a 22% increase in the survival time of pancreatic cancer patients, compared with gemcitabine alone. The firm added that, after 12 months, a higher percentage of the combined-treatment group were alive than those who received chemotherapy alone (24% versus 19%).