Roche’s advanced breast cancer drug approved in EU

The European Commission has approved Roche's Kadcyla for advanced HER2-positive breast cancer.

The decision is based on results from a phase three clinical trial, which found that patients with HER2-positive advanced breast cancer who were treated with Kadcyla survived almost six months longer than those receiving the standard treatment of lapatinib and Xeloda.

"Kadcyla's approval in the EU is important because this type of targeted medicine has been shown in clinical studies to offer clear benefits for people with advanced HER2-positive breast cancer. Now that Kadcyla has been approved, we can begin discussions with the relevant EU reimbursement authorities to ensure that people who need this medicine can receive it as quickly as possible."

Hal Barron, M.D., Roche's Chief Medical Officer and Head of Global Product Development.

More than 70,000 people in Europe each year are diagnosed with advanced breast cancer, of whom approximately one in five will have HER2-positive disease.

Kadcyla is the third targeted medicine developed by Roche for the treatment of HER2-positive breast cancer. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.