Kadcyla Approved in US for Some HER2-positive Early Breast Cancer Patients

Kadcyla Approved in US for Some HER2-positive Early Breast Cancer Patients
The U.S. Food and Drug Administration (FDA) has extended the use of Genentech's Kadcyla (ado-trastuzumab emtansine) as an adjuvant (post-surgery) treatment for some patients with HER2-positive, early-stage breast cancer, the company announced. Specifically, the FDA's approval is for patients who had residual disease after their pre-surgery treatment, which included a taxane and Herceptin (trastuzumab). This label extension was reviewed under the FDA’s real-time oncology review and assessment aid pilot programs, meant to explore a more efficient review process that brings safe and effective treatments to patients more quickly. “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,” Sandra Horning, MD, said in a press release. Horning is chief medical officer and head of Global Product Development at Genentech. Aiming to provide early breast cancer patients the best chance for a cure, patients often are treated with chemotherapy both before and after their breast cancer surgery. The first chemotherapy regimen aims to shrink tumors, improving surgical outcomes, while the second aims to eliminate the remaining cancer cells and reduce the risk of the cancer returning. “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,” Horning said. Kadcyla is an antibody-drug conjugate that uses the trastuzumab antibody (the active ingredient in Herceptin) to deli
Subscribe or to access all post and page content.