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FDA Approves Targeted Late-Stage Breast Cancer Drug

Update Date: Feb 22, 2013 09:17 PM EST

In a new breakthrough in the fight against breast cancer, the Food and Drug Administration approved a new type of drug on Friday which is a hybrid between the commonly used breast cancer medicine Herceptin and a potent toxin which targets tumors, while minimizing damage to other cells.

The new drug called Kadcyla, manufactured by Roche, combines the Herceptin drug with a highly toxic chemotherapy drug, DM1, to create a more tolerable drug that is easier to absorb. DM1by itself is too toxic to deliver directly into the bloodstream.

Kadcyla, which was referred to as T-DM1 during its three-year-long clinical research, is made as a new form of therapy for women HER2-positive breast cancer, the Food and Drug Administration said in its approval announcement. In HER2-positive breast cancers, the increased amount of the protein contributes to cancer call growth and survival. Almost 20 percent of breast cancers have increased amounts of HER2.

According to an Associated Press report, the chemical keeps the drug combination intact until it binds to a cancer cell and delivers its anti-tumor cocktail.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement. The drug is the fourth approved to target the HER2 protein.

During the clinical trials, over 1,000 women were treated with Roche's drug Herceptin and a taxane chemotherapy. Patients who were given Kadcyla survived an average of 30.9 months, compared with 25.1 months for those in the control arm who took Herceptin and GlaxoSmithKline Plc's Tykerb.

The new drug will cost $9,800 a month. According to Roche, a full course of Kadcly lasts nine months, costing $94,000 for the treatment.

In the U.S., Breast cancer is the second-leading cause of cancer-related death among women. According to the National Cancer Institute predictions, around 232,340 women will be diagnosed with breast cancer this year,  and 39,620 will die from it.

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