The U.S. Food and Drug Administratino has approved Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. The approval is based on data showing Kadcyla cut the risk of disease recurring by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast cancer.
The application was approved in just over 12 weeks under the US FDA’s Real-Time Oncology Review pilot program. Kadcyla is the first Roche medicine approved under the RTOR pilot programme, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.For this indication, Kadcyla was also granted Breakthrough Therapy Designation.
This approval 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 as an adjuvant treatment in people with HER2-positive eBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment.
Read the full Roche release