Posted by Michael Wonder on 17 Nov 2019
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment
15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast cancer.
Roche today announced that the EMA's 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 neo-adjuvant (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 neo-adjuvant taxane and Herceptin-based treatment.
