Novel cancer drug for approval filed by Roche

cancerOn Wednesday it was announced by Roche Holding AG (ROG. VX) that an application with the U. S. Food and Drug Administration has been filed for treating advanced breast cancer by making a novel cancer drug.

Being the first conjugated monoclonal antibodies to be reviewed by the FDA, the drug is known as trastuzumab-DM1 or T-DM1. Analysts have stated that it is believed to be promising in treating some breast cancer patients.

Marketing approval would be won by next six months if priority review were granted. Analysts added that blockbuster Herceptin could be replaced at some stage.

Andrew Weiss of Bank Vontobel said, "Conjugated monoclonal antibodies such as T-DM1 are viewed by thought leaders in oncology as one of the next area of significant innovation for the treatment of cancer."

Unlike the chemotherapy that also kills healthy cells, T-DM1, which was developed by Roche's unit Genentech and Immunogen Inc. (IMGN), would destroy only cancerous cells as it works by linking a monoclonal antibody and a cytotoxic, which is different from traditional methods.