Roche to file for trastuzumab emtansine this year, on positive Ph III results

Swiss drug major Roche (ROG: SIX) says that top-line results of EMILIA, the first randomized Phase III study of trastuzumab emtansine (T-DM1), show that patients with advanced metastatic breast cancer treated with T-DM1 lived significantly longer without their disease getting worse compared to patients treated with Tykerb (lapatinib) from GlaxoSmithKline (LSE: GSK).

The study enrolled people with HER2-positive metastatic breast cancer (mBC) who had previously received treatment with Roche’s blockbuster breast cancer drug Herceptin (trastuzumab) and a taxane (chemotherapy).

Based on these findings, Roche plans to submit a Marketing Authorisation Application to the European Medicines Agency this year for trastuzumab emtansine in HER2-positive mBC. In addition, its US subsidiary Genentech plans to submit a Biologics License Application for trastuzumab emtansine to the Food and Drug Administration this year for the same indication.