Roche files application to FDA for its new cancer drug T-DM1

RocheAccording to a Wednesday statement by Swiss drug maker Roche Holding AG, the company has filed an application to the US Food and Drug Administration (FDA) for a new cancer drug – called trastuzumab-DM1 (T-DM1) - for women suffering from advanced breast cancer.

As per the information forwarded by the company, T-DM1 will help the Swiss drug-maker substitute one of its best-selling cancer drugs, Herceptin, for advanced breast cancer patients.

Developed by Roche’s unit Genentech and Immunogen Inc, T-DM1 essentially links a monoclonal antibody and a cytotoxic; thereby ensuring that the drug destroys only cancerous cells; and not the healthy ones.

The submission of Roche’s application is based on phase II data that indicates T-DM1’s effectiveness in shrinking tumours in nearly one-third of the women who had, on an average, received seven prior medicines for advanced HER2-positive breast cancer.

Based on the strong trial results of the T-DM1, analysts are of the opinion that the drug, which will be one of the first conjugated monoclonal antibodies to be assessed by the FDA, has realistic chances of being approved by the FDA, for some breast cancer patients.

Noting that in case T-DM1 wins the FDA approval for some cancer patients, the drug will likely generate revenue up to CHF300 million, Bank Vontobel’s Andrew Weiss 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.”