Posted by Michael Wonder on 05 Feb 2019
Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neo-adjuvant treatment
5 February 2019 - Roche’s application is being reviewed under the US FDA's real-time oncology review and Assessment Aid pilot programmes.
Roche today announced completing the submission of a supplemental Biologics License Application to the US FDA for Kadcyla (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (eBC) with residual disease after neo-adjuvant (before surgery) treatment.
For this indication, Kadcyla was also granted breakthrough therapy designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.
This application is based on results of the phase III KATHERINE study showing 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<0.0001) compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual disease present following neoadjuvant treatment.
