FDA Approves Kadcyla For Late Stage Breast Cancer
On February 22, 2012 the U.S. Food and Drug Administration approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.
HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.
Although Kadcyla is indicated 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, the drug represents a new approach for treating breast cancer. Kadcyla is actually trastuzumab which is linked to a new component, a drug called DM-1, which interferes with the growth of cancerous cells. In efficacy trials, Kadcyla improved median survival times in breast cancer patients compared to standard therapies.
Kadcyla is being approved with a Boxed Warning (the strongest required by the FDA) alerting patients and health care professionals that the drug can cause liver toxicity, heart toxicity and death. The drug can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla treatment.
The most common side effects reported in patients treated with Kadcyla were nausea, fatigue, pain in the muscles or joints, low levels of platelets in the blood (thrombocytopenia), increased levels of liver enzymes, headache, and constipation.
Breast cancer1 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. Almost 20 percent of breast cancers have increased amounts of the HER2 protein.
Tags: breast cancer, her2, kadcyla, oncology