The European Commission has approved Roche’s Kadcyla (trastuzumab emtansine) for the adjuvant (after surgery) treatment of certain adult patients with HER2-positive early breast cancer.
The approval is for those with residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.
The approval was based on data from the company’s Phase III KATHERINE trial, which demonstrated that Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin (trastuzumab) in the adjuvant setting.
The drug significantly reduced the risk of invasive breast cancer recurrence or death from any cause by as much as 50%, and in addition 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin; an absolute improvement of 11.3%.
On the news, Kadcyla in this setting is now approved in 27 countries worldwide, and the use of Kadcyla in early breast cancer has been recommended by multiple treatment guidelines.
Further to the findings, the safety profile of Kadcyla was consistent with that observed in previous studies.
“Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
He continued, “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."
The goal of neoadjuvant treatment is to shrink tumours in order to help improve surgical outcomes, and adjuvant treatment aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning. People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.