Genentech Submits sBLA for Adjuvant Use of Breast Cancer Treatment Kadcyla

Genentech announced the submission of its supplemental Biologics License Application (sBLA) to the FDA for ado-trastuzumab emtansine (Kadcyla) for adjuvant treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) who have residual disease after neoadjuvant treatment, according to a press release.

Ado-trastuzumab emtansine, an antibody-drug conjugate, was also granted Breakthrough Therapy Designation for this indication. Currently, it is approved for the treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab (Herceptin) and a taxane.

The application is based on data from the phase 3 KATHERINE study. The study evaluated the safety and efficacy of ado-trastuzumab emtansine compared with trastuzumab as an adjuvant therapy in individuals with HER2-positive EBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy.

The study showed that ado-trastuzumab emtansine significantly reduced the risk of invasive breast cancer recurrence or death from a cause by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) versus trastuzumab as an adjuvant therapy. At 3 years, 88% of patients treated with ado-trastuzumab emtansine did not have their breast cancer return compared with 77% treated with trastuzumab, according to the data.

“Kadcyla was granted Breakthrough Therapy Designation and is also the first Genentech medicine to be reviewed under the FDA’s Real-Time Oncology Review pilot program; both FDA initiatives aim to expedite reviews and bring medicines to patients sooner,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release. “We are working closely with the FDA to bring Kadcyla to people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy as early as possible.”

In the study, the most common grade 3-4 adverse effects associated with ado-trastuzumab emtansine 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 a decrease in red blood cells.

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, according to Genentech.

Genentech is a member of the Roche Group.

Reference

Genentech Submits Supplemental Biologics License Application to FDA For Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment [news release]. Genentech. https://www.gene.com/media/press-releases/14776/2019-02-04/genentech-submits-supplemental-biologics. Accessed February 5, 2019.