Medication Monitor

Generic Name (Trade Name—Company)
June 5, 2019

Ado-trastuzumab emtansine

New indication approved for treatment of HER2-positive early breast cancer

FDA approved ado-trastuzumab emtansine for adjuvant treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment.

FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, leading to an approval 12 weeks after completing the submission. Ado-trastuzumab emtansine is the first Genentech medicine approved under the RTOR pilot program. Ado-trastuzumab emtansine 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.

Approval was based on results of the Phase III KATHERINE study showing ado-trastuzumab emtansine significantly reduced the risk of invasive breast cancer recurrence or death from any cause. At 3 years, 88.3% of people treated with ado-trastuzumab emtansine did not have their breast cancer return, compared with 77.0% treated with trastuzumab. People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.

The most common adverse effects (>25%) with ado-trastuzumab emtansine 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.

The goal in treating EBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery and aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.