FDA Approves First Angiogenesis Inhibitor To Treat Colorectal Cancer -- ScienceDaily
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`FDA ApprovesFirst Angiogenesis Inhibitor
`To Treat Colorectal Cancer
`
`Date:
`
`February 27, 2004
`
`Source:
`
`U.S. Food And Drug Administration
`
`Most Popular
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`HEALTH & MEDICINE
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`Summary: The FDA has approved Avastin (bevacizumab)asafirst-line
`Sugar Levels Independentof Insulin
`treatment for patients with metastatic colorectal cancer--
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`FULL STORY
`
`February 26, 2004 -- The U.S. Food and Drug
`Administration today approved Avastin (bevacizumab) as a
`first-line treatment for patients with metastatic colorectal
`cancer-- cancer that has spread to other parts of the body.
`Avastin, a monoclonal antibody,is the first product to be
`approved that works by preventing the formation of new
`blood vessels, a process knownas angiogenesis. Avastin
`was shownto extendpatients’ lives by about five months
`whengiven intravenously as a combination treatment along
`with standard chemotherapy drugsfor colon cancer (the
`"Saltz regimen" also knownasIFL). IFL treatment includes
`ironotecan, 5-fluorouracil (SFU) and leucovorin.
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`Mylan v. Regeneron, IPR2021-00881
`U.S. Pat. 9,254,338, Exhibit 2261
`
`ly.com/releases/2004/02/040227071334htm 1/12/2022 4:06:06 PM]
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`FDA Approves First Angiogenesis Inhibitor To Treat Colorectal Cancer -- ScienceDaily
`
`Avastin is a genetically engineered version of a mouse antibody that
`contains both human and mouse components.(Antibodies are substances
`produced by the body's immune system to fight foreign substances.) Special
`technology also allows it to be producedin large quantities in the laboratory.
`
`This new monoclonal antibody is believed to work by targeting and inhibiting
`the function of a natural protein called "vascular endothelial growth factor"
`(VEGF)that stimulates new blood vessel formation. When VEGFis targeted
`and boundto Avastin, it cannot stimulate the growth of blood vessels, thus
`denying tumors blood, oxygen and othernutrients needed for growth.
`Angiogenesis inhibitors such as Avastin have been studied, first in the
`laboratory and thenin patients, for three decades with the hope they might
`prevent the growth of cancer. Thisis the first such product that has been
`proven to delay tumor growth and more importantly, significantly extend the
`lives of patients.
`
`"The approval of Avastin is the result of many years of research and
`development exploring a promising new approach to fighting cancer, andit
`is one of a numberof recent new treatments for colorectal cancer that taken
`
`together, have significantly improved the armamentarium forfighting this
`disease," said Mark B. McClellan, M.D., Ph.D., FDA Commissioner. "These
`medical achievementsreflect the innovation of drug developers and the hard
`work of FDA's cancer review teams, and theyare proof of the promise
`offered by biomedical innovation. The dedication of everyone involved in
`these efforts is making a real difference in the lives of cancer patients."
`
`Colorectal cancer-- cancer of the colon or rectum -- is the third most
`
`commoncanceraffecting men and womenin the U.S. and, according to the
`Centers for Disease Control and Prevention (CDC), is the second leading
`cause of cancer-related death. Colorectal cancer is also one of the most
`
`commonly diagnosed cancers in the U.S.; approximately 147,500 new cases
`were diagnosedin 2003.
`
`The safety and efficacy of Avastin was primarily shown in a randomized,
`
`Exhibit 2261
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`Page 02 of 05
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`https://www.sciencedaily.com/releases/2004/02/040227071334.htm[1/12/2022 4:06:06 PM]
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`Exhibit 2261
`Page 02 of 05
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`FDA Approves First Angiogenesis Inhibitor To Treat Colorectal Cancer -- ScienceDaily
`
`double-blind clinical trial of more than 800 patients with metastatic colorectal
`cancer designed to find out whether Avastin extended the lives of patients.
`Roughly half the patients received IFL, the standard chemotherapy
`combination, and the other half received Avastin once every two weeksin
`addition to IFL. Overall, patients given Avastin in combination with IFL
`survived about five months longer and the average time before tumors
`started regrowing or new tumors appeared wasfour months longer than
`patients receiving IFL alone. The overall responserate to the treatment was
`45% compared to 35% for the control arm ofthetrial.
`
`Serious, but uncommon,side-effects of Avastin include formation of holesin
`the colon (gastrointestinal perforation) generally requiring surgery and
`sometimesleading to intra-abdominal infections, impaired wound healing,
`and bleeding from the lungsorinternally. Other, more common,side-effects
`are high blood pressure,tiredness, blood clots, diarrhea, decreased white
`blood cells (lowering immunity to diseases) headache, appetite loss and
`mouth sores.
`
`Avastin is manufactured by Genentech, Inc., South San Francisco, Calif.
`
`Story Source:
`
`Materials provided by U.S. Food And Drug Administration. Note: Content
`maybe edited for style and length.
`
`Cite This Page:
`
`MLA
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`APA
`
`.
`Chicago
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`U.S. Food And Drug Administration. "FDA Approves First Angiogenesis
`Inhibitor To Treat Colorectal Cancer." ScienceDaily. ScienceDaily, 27
`February 2004.
`<www.sciencedaily.com/releases/2004/02/040227071334.htm>.
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`FDA Approves First Angiogenesis Inhibitor To Treat Colorectal Cancer -- ScienceDaily
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`FDA ApprovesFirst Angiogenesis Inhibitor To Treat Colorectal Cancer -- ScienceDaily
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`Exhibit 2261
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`ily.com/releases/2004/02/040227071334.htm[1/12/2022 4:06:06 PM]
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