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FDA Approves Kadcyla for Early Breast Cancer

Earlier this month, the FDA approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) 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.1

Kadcyla HER2-positive breast cancer approvals

The National Cancer Institute defines residual disease as “cancer cells that remain after attempts to remove the cancer have been made.” Kadcyla consists of a HER2-targeted antibody and the chemotherapy agent DM1 that was previously approved for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.2 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.

What is Kadcyla and how is it used to treat breast cancer?

Kadcyla is a targeted therapy called an antibody-drug conjugate. HER2+ breast cancer is characterized by tumors that overproduce a specific molecule known as human epidermal growth factor receptor-2, or HER2.

Kadcyla priority review

At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%. It should be noted that people who have cancer cells remaining after the neoadjuvant treatment often have worse outcomes than people who no detectable disease.3

Focus on reducing risk of breast cancer recurrence and progression

Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genentech spoke about the importance of this approval in terms of accessibility and reduction of recurrence. “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. 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.”3

  1. FDA approves ado-trastuzumab emtansine for early breast cancer. US FDA. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ado-trastuzumab-emtansine-early-breast-cancer. Accessed May 13, 2019.
  2. KADCYLA Prescribing Information. Genentech. https://www.gene.com/download/pdf/kadcyla_prescribing.pdf. Accessed May 13, 2019.
  3. FDA Approves Genentech's Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment. Genentech. https://www.gene.com/media/press-releases/14785/2019-05-03/fda-approves-genentechs-kadcyla-for-adju. Accessed May 13, 2019.

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