EU approves Kadcyla for HER2-positive early breast cancer with residual invasive disease.- Roche

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

The approval of Kadcyla in Europe 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 (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.001) compared to herceptin trastuzumab as an adjuvant treatment in people with her2-positive ebc who have residual invasive disease after neoadjuvant taxane and herceptin-based treatment. at three years 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. the safety profile of kadcyla was consistent with that observed in previous studies.>

Comment: Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1.