Roche Holding AG said the European Commission approved Kadcyla for treating certain patients with breast cancer.
Kadcyla, or trastuzumab emtansine, can now be used in the EU as a postsurgery therapy for adults with HER2-positive early breast cancer. These patients also have residual invasive disease in the breast and/or lymph nodes, having received taxane-based and HER2-targeted therapy prior to surgery.
The goal of presurgery therapy is to shrink tumors, helping improve surgical outcomes. Postsurgery treatment aims to get rid of any remaining cancer cells in the body, cutting down the risk of the disease coming back.
Patients with residual disease after presurgery treatment have worse disease progression than those with no detectable disease, the Swiss drugmaker noted.
The EC approval of Kadcyla is based on results from a late-stage study named Katherine, in which the drug significantly reduced the risk of invasive breast cancer returning or death from any cause by 50%, compared to Roche's other breast cancer medicine, Herceptin.
Kadcyla is also approved in the U.S. for the same indication. Roche licenses technology for the drug under a deal with ImmunoGen Inc.