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FDA Approves Kadcyla, Breast-Cancer Drug from Roche, ImmunoGen

02/22/2013 | 11:26am US/Eastern
   By Jennifer Corbett Dooren 

WASHINGTON--The U.S. Food and Drug Administration Friday approved a powerful new type of drug that will be marketed by Roche Holding AG (ROG.VX, RHHBY) to treat breast cancer.

The drug called, Kadcyla, combines Roche's existing cancer drug, Herceptin, with a powerful chemotherapy agent.

Herceptin targets a protein called HER2 found on tumors in about 20% to 25% of breast-cancer patients. The two other components of Kadcyla, both developed by ImmunoGen Inc. (>> ImmunoGen, Inc.), are a chemotherapy agent called emtansine that is too potent to be delivered as a conventional medicine, and a linker that connects the two drugs. Herceptin then delivers the package to the tumor cell, where it releases the toxic cargo to kill the cancer.

The FDA's approval of Kadcyla, which was previously known as T-DM1, triggers a $10.5 million payment to ImmunoGen by Roche. ImmunoGen will also receive royalties on sales.

Roche's Genentech unit said Kadcyla will be available to patients in about two weeks. The drug will be priced at $9,800 a month. The company said there will be a patient-assistance program to help pay for the product.

The approval of Kadcyla was based on a study of about 1,000 women with HER2-positive breast cancer who had been treated previously with Herceptin and a traditional chemotherapy drug. About half of the women were then treated with T-DM1 and the other half were treated with a combination of Xeloda, another Roche drug, and GlaxoSmithKline PLC's (GSK, GSK.LN) Tykerb. The drugs were administered every three weeks until the disease progressed or patients experienced unmanageable side effects.

The study was designed to measure progression-free survival, which is a measurement of the time from the start of treatment until the disease gets worse or the patient dies, and overall survival, which is a measurement of time from the start of treatment until death.

The median progression-free survival for patients receiving T-DM1 was 9.6 months, compared with 6.4 months in the group receiving Xeloda and Tykerb, a difference considered statistically significant. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months for Xeloda and Tykerb group.

Write to Jennifer Corbett Dooren at

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