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FDA Approves Breast-Cancer Drug

02/22/2013 | 12:05pm US/Eastern

--Drug packs Roche's Herceptin with chemotherapy agent

--Drug approved for use as a first-line, or initial treatment for advanced breast cancer

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, and is meant to treat certain types of breast cancer that have spread to other parts of the body.

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 of up to 5%.

Analysts said the approval was broader than expected. The drug can be marketed for initial treatment rather than just in patients who've tried other therapies, creating a "significantly larger patient population," said Simos Simeondis, an analyst at Cowen and Company.

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.

Agents like Kadcyla are called antibody-drug conjugates and they are the focus of intense interest in the pharmaceutical industry. Roche's Genentech unit has 25 such agents under development for different cancers, including eight in human studies.

The first such agent to gain FDA approval was Seattle Genetics Inc.'s (>> Seattle Genetics, Inc.) Adcetris, for Hodgkin's Lymphoma and another rare cancer. That company and ImmunoGen are each collaborating with big pharmaceutical firms including Bayer AG (BAYRY, BAYN.XE), Eli Lilly & Co. (>> Eli Lilly & Co.), GlaxoSmith Kline PLC (GSK, GSK.LN), Pfizer Inc. (>> Pfizer Inc.), Sanofi (>> Sanofi SA) to develop several types of new cancer drugs.

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's Tykerb. The study showed women receiving Kadcyla lived for an average of 31 months, which was about six months longer than women being treated with Xeloda and Tykerb.

However, like other cancer drugs Kadcyla has the potential to cause serious and life-threatening side effects from liver damage or heart problems. The drug can also cause severe birth defects so doctors need to make sure women of child-bearing age aren't pregnant before administering the product.

--Joseph Walker contributed to this story.

Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

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