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European Regulators Recommend Approval of Roche Treatment for HER2-Positive Breast Cancer

NEW YORK – Roche said on Friday that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its trastuzumab emtansine (Kadcyla) antibody-drug conjugate for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.

Trastuzumab emtansine is engineered to deliver chemotherapeutic agents directly to HER2-positive cancer cells. It combines the HER2-targeting properties of trastuzumab and the chemotherapy agent DM1.

The recommendation from the CHMP is based on results from the phase III KATHERINE study, an international, multi-center, two-arm, randomized, open-label study evaluating the efficacy and safety of trastuzumab emtansine compared to trastuzumab (Herceptin) as an adjuvant therapy in people with HER2-positive early breast cancer who have pathological invasive residual disease in the breast or axillary lymph nodes following neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy.

The study showed that trastuzumab emtansine significantly reduced the risk of invasive breast cancer recurrence or death from any cause (defined as invasive-disease-free survival) by 50 percent. At three years, 88.3 percent of people treated with trastuzumab emtansine did not see a recurrence of breast cancer compared to 77 percent of those treated with trastuzumab.

The KATHERINE study data was also used by the US Food and Drug Administration to accelerate the approval of trastuzumab emtansine for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment in May.

Based on the CHMP's recommendation, Roche said it expects a final decision regarding approval of trastuzumab emtansine in this setting from the European Commission in the near future.

"In the early breast cancer setting where cure is achievable, it is important to do everything possible to prevent progression to an advanced, incurable stage," Roche Chief Medical Officer Levi Garraway said in a statement. "This recommendation therefore marks a significant step forward in bringing a potentially transformative treatment option to patients in Europe with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy."