US FDA approves Genentech’s new breast cancer therapy

Hannah Blake


Roche’s Genentech has announced that the US FDA has approved its new breast cancer therapy, Kadcyla.

Kadcyla (ado-trastuzumab emtansine) is a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. It has been approved for the intention of being used with 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. 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.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Kadcyla was reviewed under the FDA’s priority review program, which provides an expedited six-month review of drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.

Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute.


Reference links:

Roche press release

FDA press release

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