Adjuvant breast cancer approval for Roche's Kadcyla in EU

The European Commission (EC) has approved Kadcyla (trastuzumab emtansine) for the adjuvant treatment of adults with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy.

This approval of the Roche (ROG: SIX) drug is based on results from the Phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to the Swiss company's older drug Herceptin (trastuzumab) as an adjuvant treatment in this patient group.

Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible.