FDA approves Roche drug for late-stage metastatic breast cancer

Fri Feb 22, 2013 9:39am EST

Feb 22 (Reuters) - U.S. health regulators said on Friday they have approved a new drug made by Roche Holding AG for some patients with late-stage metastatic breast cancer who have failed other therapies.

The U.S. Food and Drug Administration said it 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 toxicity 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 the control group.

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