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FDA OKs Roche drug for late-stage metastatic breast cancer

Last Updated: 2013-02-22 12:44:08 -0400 (Reuters Health)

(Reuters) - U.S. health regulators approved a new drug made by Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.

The U.S. Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.

The drug's label will carry a boxed warning, the most serious possible, of the drug's potential to cause liver and heart damage and death. The drug can also cause life-threatening birth defects.

In clinical trials, patients who took the drug, known during its development process as T-DM1, survived an average of 30.9 months, compared with 25.1 months in a control group.

Analysts at Jefferies have estimated the drug could generate annual peak sales of $1.9 billion as usage in different settings increases.

Kadcyla works by attaching trastuzumab, sold under the brand name Herceptin, to a drug called DM1 that interferes with cancer cell growth, said Dr. Richard Pazdur, director of the FDA's office of hematology and oncology products.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," he said. "It is the fourth approved drug that targets the HER2 protein."

Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with the disease in 2013 and 39,620 will die from it, according to the National Cancer Institute. About 20 percent of breast cancer patients have increased amounts of the HER2 protein.

The most common side effects in patients treated with Kadcyla were nausea, fatigue, muscle and joint pain, increased liver enzymes, headache and constipation.

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