The U.S. Food and Drug Administration has approved Kadcyla (ado-trastuzumab emtansine) for patients with HER2-positive metastatic breast cancer.
In HER2-positive breast cancer, HER2-- a protein involved in normal cell growth-- appears in increased amounts and contributes to cancer cell growth and survival.
Kadcyla is designed for patients previously treated with another HER2-positive therapy, trastuzumab, along with a class of chemotherapy drugs known as taxanes.
Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research:
"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.”
Kadcyla was known as T-DM1 while in development and was part of the FDA's priority review program. It joins trastuzumab (1998), lapatinib (2007) and pertuzumab (2012) in the treatment of HER2-positive breast cancers.
Kadcyla comes with a Boxed Warning alerting patients and health care professionals that the drug can cause liver toxicity, heart toxicity and death. It may also cause severe life-threatening birth defects.
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