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
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