The European Commission announced the approval of Kadcyla (trastuzumab emtansine) for adjuvant (after surgery) treatment of patients with “HER2-positive” early breast cancer.
CMO and Head of Global Product Development of Roche Dr. Levi Garraway said, “Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible. This approval of Kadcyla will allow many more women with HER2-positive early breast cancer to be given a transformative treatment that may cut the risk of their disease returning or progressing.”
Patients with residual disease after neoadjuvant treatment often have a bad prognosis. The goal of the adjuvant treatment with Kadcyla is to shrink tumors, thereby improving surgical outcomes and reducing the risk of cancer recurrence.
The EU approval of Kadcyla is based on the findings of clinical trials, which showed that the drug significantly reduced the risk of cancer recurrence and death from any cause compared to Herceptin (trastuzumab) as adjuvant therapy for HER2-positive early breast cancer.
After three years of clinical trials, more than 88 percent of people who received Kadcyla did not have their breast cancer return when compared with 77 percent who received Herceptin. In addition, the safety profile of Kadcyla was consistent throughout the studies.
In the United States, Kadcyla has already been found effective as adjuvant therapy for HER2-positive early breast cancer. In fact, women have already been prescribed the drug following FDA approval in May. Kadcyla has now been approved in 27 nations and its use in early breast cancer has been recommended by multiple treatment guidelines.
