FDA Approves First-Of-Its-Kind Breast Cancer Drug
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`December 5, 2014
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`FDA Approves First-Of-Its-Kind
`Breast Cancer Drug
`
` | By MATTHEW PERRONE
`
`Posted: 02/22/2013 12:30 pm EST
`
`Updated: 02/18/2014 8:59 am EST
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`The Food and Drug Administration has approved a first-of-a-kind breast cancer
`medication that targets tumor cells while sparing healthy ones.
`
`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
`potent dose of anti-tumor poison.
`
`Cancer researchers say the drug is an important step forward because it delivers
`more medication while reducing the unpleasant side effects of chemotherapy.
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`"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."
`
`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. 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.
`
`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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`http://www.huffingtonpost.com/2013/02/22/fda-approves-new-breast-cancer-drug-kadcyla_n_2742241.html[12/5/2014 10:43:15 AM]
`
`IMMUNOGEN 2133, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`
`FDA Approves First-Of-Its-Kind Breast Cancer Drug
`
`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.
`
`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. Doctors are not required to follow FDA prescribing guidelines, and cancer
`researchers say the drug could have great potential in patients with earlier forms of
`breast cancer
`
`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 using drug-
`binding technology licensed from Waltham, Mass.-based ImmunoGen. The company
`developed the chemical that keeps the drug cocktail together and is scheduled to
`receive a $10.5 million payment from Genentech on the FDA decision. The company
`will also receive additional royalties on the drug's sales.
`
`Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock
`has ttraded in a 52-wek range of $10.85 to $18.10.
`
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`Kadcyla Breast Cancer Drug, Kadcyla, Breast Cancer, New Breast Cancer Drug Approved, Breast
`MORE:
`Cancer Drug Approved, Breast Cancer Drug, Kadcyla Approved,
`
`Suggest a
`correction
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`http://www.huffingtonpost.com/2013/02/22/fda-approves-new-breast-cancer-drug-kadcyla_n_2742241.html[12/5/2014 10:43:15 AM]
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`IMMUNOGEN 2133, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`
`FDA Approves First-Of-Its-Kind Breast Cancer Drug
`
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`http://www.huffingtonpost.com/2013/02/22/fda-approves-new-breast-cancer-drug-kadcyla_n_2742241.html[12/5/2014 10:43:15 AM]
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`IMMUNOGEN 2133, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676