SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug maker Roche Group (RHHBY) announced Thursday that the European Commission has approved Kadcyla (trastuzumab emtansine) for the adjuvant (after surgery) treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant (before surgery)treatment.
The approval was based on the phase III KATHERINE trial data showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death by half compared to Herceptin (trastuzumab) as an adjuvant treatment.
Kadcyla is approved in Europe for the adjuvant treatment of adult patients with HER2-positive early breast cancer or eBC who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy.
The goal of neoadjuvant treatment is to shrink tumours in order to help improve surgical outcomes. 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.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said, '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.'
In the US, the Food and Drug Administration approved the adjuvant treatment with Kadcyla in May, following which thousands of women are already being given this treatment.
Kadcyla in this setting is now approved in 27 countries worldwide and the use of Kadcyla in eBC has been recommended by multiple treatment guidelines.
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