COMMITTEE ENDORSES EXPANDED INDICATIONS FOR ROCHE CANCER DRUGS

Swiss drugmaker Roche recently announced it has received two positive opinions from the European Medicines Agency Committee for Medicinal Products for Human Use. The committee recommended approving Avastin as a first-line treatment of metastatic breast cancer and Xeloda for the treatment of advanced gastric cancer.

The recommendation for Avastin is for use in combination with standard chemotherapy paclitaxel in previously untreated metastatic breast cancer. The committee's decision was based on Phase III trial data that show that women with metastatic breast cancer have the chance to live twice as long without their cancer progressing if treated with Avastin in addition to paclitaxel compared with paclitaxel alone, according to Roche.

The drug is currently approved for treating colorectal cancer, and Roche has also submitted an application for its use in treating lung cancer.

The committee also endorsed the use of Xeloda in combination with platinum-based chemotherapy for treating advanced stomach cancer. The recommendation was based on two Phase III studies, one of which showed that patients treated with Xeloda in addition to standard therapy lived significantly longer than those treated with standard therapy alone.

Xeloda is already approved for treating colorectal and breast cancer.