FDA Approves a New Drug For Late Stage Breast Cancer

First Posted: Feb 23, 2013 06:42 AM EST

The Roche Group got a nod from the U.S. Food and Drug Administration for 'Kadcyla', a new therapy to treat patients with HER2-positive - a late stage breast cancer. This is the first of its kind breast cancer medication as the drug not only reduces the size of the tumor but also slows the progress of the disease.  

HER2 is a gene that plays a vital role in the development of breast cancer. This  gene makes HER2 proteins that are receptors of breast cells.

Kadcyla is a new therapy for those patients who have been previously treated with trastuzumab an anti HER2 therapy. Trastuzumab is a monoclonal antibody and is commonly use to treat breast cancer as it infers with the HER2 protein.

"Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research said in a press statement. "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."

During the clinical research, Kadcyla was referred to as T-DM1. According to the reports, the other FDA approved drug that are used to treat HER-2 positive breast cancer are trastuzumab (1998), lapatinib (2007) and pertuzumab (2012).

A clinical study on 991 patients checked the safety and effectiveness of the new therapy Kadcyla. The patients either received Kadcyla or lapatinib plus capecitabine, another chemotherapy drug. The patients were given the treatment until the cancer advanced or the side effects became intolerable.

With this study the researchers measured the progression-free survival, the length of time patients lived without the cancer progressing and overall survival.

It was seen that those who were treated with Kadcyla had a median progression free survival of 9.6 months compared to 6.4 months in patients treated with lapatinib plus capecitabine. And they lived for an average of 31 months six months longer than the ones treated with lapatinib plus capecitabine.  

The side effects of Kadcyla is pain in joints and muscles, fatigue, nausea, low levels of platelets in the blood, headache, constipation and high level of enzymes. 

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