Recently Roche Holding said it has filed an application to the U.S. Food and Drug Administration for a novel cancer drug called trastuzumab-DM1, or T-DM1, the drug hoped could help the Swiss pharma giant replace its Herceptin cure for women with advanced breast cancer.
The drug is the first conjugated monoclonal antibody to be reviewed by the FDA and has realistic chances to be approved in some breast cancer patients by the regulator given the medicine’s strong trial results, analysts said.
T-DM1, which was developed by Roche’s unit Genentech and Immunogen Inc.,works differently from traditional cancer treatments as the medicine links a monoclonal antibody and a cytotoxic. This makes sure that only cancerous cells are destroyed, unlike in chemotherapy that also kills healthy cells.
Roche said that it has submitted a biologics licence application for the treatment of people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.
The submission is based on phase II data which showed T-DM1 shrank tumours in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer. Roche is continuing with T-DM1 trials.
