FDA Approves Kadcyla for Adjuvant Treatment of Patients With HER2-Positive Early Breast Cancer

The Food and Drug Administration (FDA) approved Kadcyla (ado-trastuzumab emtansine) for adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and Herceptin (trastuzumab)-based treatment.

The approval is based on findings from the phase 3 KATHERINE study showing Kadcyla lowers the risk of disease recurrence by 50% compared to Herceptin in the adjuvant setting for this patient population.

The FDA reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, granting the approval 12 weeks after its submission. Kadcyla is the first Genentech drug to be approved under the RTOR pilot program, which is working towards a more efficient review process to give patients safe and effective treatments as soon as possible.

“This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development for Genentech, the manufacturer of Kadcyla. “With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.”

At three years into the KATHERINE study, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin — an 11.3% absolute improvement. This is important, considering that people who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.

The most common grade 3 or higher side effects (greater than 2%) with Kadcyla in the KATHERINE study were decreased platelet count and high blood pressure. The most common all-grade side effects (greater than 25%) with Kadcyla were fatigue; nausea; increased blood levels of liver enzymes; musculoskeletal pain; bleeding; decreased platelet count; headache; numbness, tingling or pain in the hands or feet; and joint pain.