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`CBS/AP / February 22, 2013, 5:33 PM /
`
`FDA approves new late-stage
`breast cancer drug Kadcyla
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`FILE - In this Thursday, May 6, 2010 file photo, a radiologist uses a magnifying glass to check mammograms for
`breast cancer in Los Angeles. A big U.S. study published in the Thursday, Nov. 22, 2012 New England Journal of
`Medicine shows that mammograms have done surprisingly little to catch deadly cancers before they spread. At the
`same time, they have led more than a million women to be treated for growths that never would have threatened
`their lives. (AP Photo/Damian Dovarganes, File) / AP
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`WASHINGTON | A first-of-a-kind breast cancer medication that targets tumor cells
`while sparing healthy ones has been approved by the Food and Drug
`Administration.
`
`The drug Kadcyla from Roche combines the established drug Herceptin with a
`powerful chemotherapy drug and a third chemical linking the medicines together.
`The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a
`double-shot of anti-tumor poison.
`
`Cancer researchers say the drug may offer a clear advantage over older drugs
`
`IMMUNOGEN 2021, pg. 1
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`because it delivers more medication with fewer side effects.
`
`"This antibody goes seeking out the tumor cells, gets internalized and then
`explodes them from within. So it's very kind and gentle on the patients - there's no
`hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University
`Medical Center. "It's a revolutionary way of treating cancer."
`
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`Cobleigh helped conduct the key studies of the drug at the Chicago facility.
`
`The FDA approved the new treatment for about 20 percent of breast cancer
`patients with a form of the disease that is typically more aggressive and less
`responsive to hormone therapy. These patients have tumors that overproduce a
`protein known as HER-2.
`
`"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease
`progression and prolong survival," Dr. Richard Pazdur, director of the Office of
`Hematology and Oncology Products at the FDA, said in a press release. "It is the
`fourth approved drug that targets the HER2 protein."
`
`The approval will help Roche's Genentech unit build on the blockbuster success of
`Herceptin, which has long dominated the breast cancer marketplace. The drug
`had sales of roughly $6 billion last year.
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`Most Shared
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`Genentech said Friday that Kadcyla will cost $9,800 per month, compared to
`$4,500 per month for regular Herceptin. The company estimates a full course of
`Kadcyla, about nine months of medicine, will cost $94,000.
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`
`FDA scientists said they approved the drug based on company studies showing
`Kadcyla delayed the progression of breast cancer by several months. Researchers
`reported last year that patients treated with the drug lived 9.6 months before
`death or the spread of their disease, compared with a little more than six months
`for patients treated with two other standard drugs, Tykerb and Xeloda.
`
`Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for
`patients taking the other drugs.
`
`FDA specifically approved the drug for patients with advanced breast cancer who
`have already been treated with Herceptin and taxane, a widely used
`chemotherapy drug.
`
`Kadcyla will carry a boxed warning, the most severe type, alerting doctors and
`patients that the drug can cause liver toxicity, heart problems and potentially
`death. The drug can also cause severe birth defects and should not be used by
`pregnant women.
`
`Kadcyla was developed by South San Francisco-based Genentech and used
`licensed technology from ImmunoGen Inc., of Waltham, Mass. to bind the drug
`ingredients together. ImmunoGen Inc. is scheduled to receive a $10.5 million
`payment from Genentech on the FDA decision. The company will also receive
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`IMMUNOGEN 2021, pg. 2
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`additional royalties on the drug's sales.
`
`Breast cancer is the second most deadly form of cancer in U.S. women, and is
`expected to kill more than 39,000 Americans this year, according to the National
`Cancer Institute.
`
`Editor's note: An earlier version of this story incorrectly stated that Kadcyla was
`developed by both Genetech and ImmunoGen Inc.
`
`© 2013 CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast,
`rewritten, or redistributed. The Associated Press contributed to this report.
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`IMMUNOGEN 2021, pg. 3
`Phigenix v. Immunogen
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`IMMUNOGEN 2021, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676