US FDA approves Roche's late-stage breast cancer drug Kadcyla

The US Food and Drug Administration on Friday approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer, developed by Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX).

Kadcyla, which has also been filed for approval in the Euroopean Union and Japan (The Pharma Letter January 30), is intended for patients who were previously treated with trastuzumab, another anti-HER2 therapy, and taxanes, a class of chemotherapy drugs commonly used for the treatment of breast cancer.

“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, noting that “Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein.”