CHMP recommends approval of Kadcyla for adjuvant treatment of HER2-positive early breast cancer.- Roche

Roche announced that the European Medicines Agency�s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of 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. Based on this recommendation, a final decision regarding approval of Kadcyla in this setting, along with the full details of the approved indication, is expected from the European Commission in the near future.

The recommendation from the CHMP 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 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.>