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New Breast Cancer Drug Approved by FDA

Posted on 23. Feb, 2013 by in Health, Health Featured

The new drug is named Kadcyla, but in its development was referred to as T-DM1

The new drug is named Kadcyla, but in its development was referred to as T-DM1

February 23, 2013 - On Friday, the U.S. Food and Drug Administration approved a new drug that uses a combination of a breast cancer medication, Herceptin, that is widely used, with a toxin that is highly powerful, to kill cancer cells more effectively while also potentially lowering the number of side effects.

The new drug is named Kadcyla, but in its development was referred to as T-DM1. It extended the average survival rate of women who had advanced breast cancer close to six months in one clinical trial.

The drug was developed by Genentech and the company said it would have a cost of approximately $9,800 per month or about $94,000 for a full treatment. That price is about twice the cost of Herceptin, which Genentech also manufactures, but the price is similar to some of the other newer drugs to fight cancer.

The company announced that Kadcyla would be available in days. The drug is one of the first examples of a new class of cancer drugs that have linked toxins to proteins referred to as monoclonal antibodies. Those antibodies attach to tumors and then inject the toxic payload into the tumor. Since the toxin is inactive until it latches onto the tumor, cells that are healthy get spared and some of the side effects do not take place.

These types of drugs have become an important for those who develop cancer drugs. Close to two dozen of these drugs are currently being tested in clinical trials. Adcertis, another of the antibody drug conjugates, which Seattle Genetics developed, received approval in 2011 for the treatment of two rare forms of lymphoma.

The clinical trial that led to Kadcyla to be approved involved more than 990 patients who suffered from breast cancer that was metastatic and worsening despite being treated with Herceptin and a chemotherapy drug. Patients received either Kadcyla infusions or two other pills, which were commonly used for patients suffering from this form of cancer.

Those receiving the Kadcyla lived an average of nearly 31 months, compared to 25 months for those receiving the pills.

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