Genentech/Roche file sBLA with FDA for Kadcycla as adjuvant treatment in HER2+ breast cancer

Genentech/Roche announced completing the submission of a supplemental Biologics License Application to the FDA for Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) with residual disease after neoadjuvant (before surgery) treatment. The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore 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, 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 percent (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. people who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease. at three years 88.3 percent of people treated with kadcyla did not have their breast cancer return compared to 77.0 percent treated with herceptin an absolute improvement of 11.3 percent.>

The most common Grade 3-4 side effects (1 percent or less) with Kadcyla in the KATHERINE study were decreased platelet count; high blood pressure; radiation-induced skin injury; numbness, tingling or pain in the hands or feet; decreased neutrophil count; low blood potassium level; fatigue and decrease in red blood cells.