Genentech’s Kadcyla Wins Second FDA Approval for HER2-Positive Breast Cancer


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Twelve weeks after filing its supplemental Biologics License Application, Genentech’s Kadcyla secured approval from the U.S. Food and Drug Administration (FDA) for a second breast cancer indication.

Late Friday, the FDA approved Kadcyla as adjuvant treatment of people with HER2-positive early breast cancer who have residual invasive disease after taxane and Herceptin-based treatment given before surgery. Genentech noted that the goal in treating early breast cancer is to ensure that people have the best chances of overcoming the disease. 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, the company said. People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.

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The regulatory approval is based on the Phase III KATHERINE study showing Kadcyla reduced the risk of disease recurring by half compared to Herceptin in these patients. 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. Approximately 15 to 20 percent of breast cancers are HER2-positive. Kadcyla was approved under the FDA’s new Real-Time Oncology Review pilot program, a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Sandra Horning, chief medical officer and head of Global Product Development at Genentech, said the latest approval of Kadcyla is a significant advance in the treatment of 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,” Horning said in a statement. “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.”

Genentech’s Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cells. It is a combination of two anti-cancer agents, the HER2-targeting trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. This latest approval is the second indication for Kadcyla in HER2-positive breast cancer. Kadcyla was previously approved for the treatment of HER2-positive metastatic breast cancer.

Genentech filed its supplemental BLA in February. The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program, which was implemented to bring products to patients as soon as possible. Kadcyla, which was also granted Breakthrough Therapy Designation, is the first Genentech product to be approved under the new system, the company said.

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