28-Feb-13 8:00 AM  CST

FDA Approves Kadcyla for the Treatment of Late-Stage Breast Cancer

The National Cancer Institute estimates that the second leading cause of cancer-related death in women is breast cancer.  Recently, the Food and Drug Administration (FDA) approved Roche Pharmaceuticals Kadcyla (trastuzumab emtansine) as a new line of therapy in treating metastatic breast cancer (mBC),  Kadcyla is for patients that have received prior breast cancer treatment with Herceptin (trastuzumab) and taxane chemotherapy.     

An FDA representative recently commented on the new drug approval.  “Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” 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 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,” also said Pazdur. 

Pharmacy technicians will want to make note of Kadcyla’s black box warning.  The drug can potentially cause liver toxicity, heart toxicity, and death.  Severe life-threatening birth defects are also a possibility.  Pregnancy status should be verified before starting breast cancer treatment with Kadcyla. 

Common side-effects associated with Kadcyla are nausea, muscle pain, joint pain, fatigue, thrombocytopenia, liver enzymes that are increased, constipation, and headaches. 
1.  Yao, Stephanie.  “FDA approves new treatment for late-stage breast cancer.”  FDA.  Web.  22 Feb 2013. 

2.  Dooren, Jennifer Corbett.  “FDA approves Kadcyla, Breast-Cancer Drug from Roche, ImmunoGen.”  Fox Business News.  Web.  22 Feb 2013.  

3.  Klauser, Alexander.  “FDA approves Roche’s Kadcyla (trastuzumab entansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer.”  Roche.  Web.  22 Feb 2013.    

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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