12/4/2014
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`Roche/Genentech's breakthrough TDM1 wins blockbuster OK for breast cancer FierceBiotech
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`NEWS TOPICS ANALYSIS FEATURES LIBRARY EVENTS JOBS MARKETPLACE
`
`Topics: Pipeline | R&D | Regulatory
`Roche/Genentech's breakthrough TDM1 wins
`blockbuster OK for breast cancer
`February 22, 2013 | By John Carroll
`
`SHARE
`
`The FDA today approved TDM1, a breakthrough antibody drug
`conjugate from Roche/Genentech widely expected to quickly
`become a new blockbuster treatment for breast cancer.
`
`71
`
`Tweet
`
`63
`
`Share
`
`0
`
`Like
`
`0
`
`Roche ($RHHBY) will market the newly approved drug as
`Kadcyla. Its partner ImmunoGen ($IMGN) stepped up with the
`ADC technology and stands to gain a small, singledigit royalty
`stream from the therapy.
`
`The drug will cost $9,800 a month,or about $94,000 for a 9.5
`month course of therapy. Analysts' peak sales projections for
`this drug have ranged from $2 billion to $5 billion a year.
`
`Hal Barron, CMO,
`head of global
`product
`development,
`Roche/Genentech
`
`Webinar: The Basics of Biotech 101, 201 & 301
`
`INDIVIDUAL SESSION: $129, FULL SERIES: $299
`This 3part webinar series is specifically geared toward the nonscience
`professional who needs to better understand industry terminology, science, techniques and
`issues. This series provides an overview of the science and technology used to enable
`discovery and the processes scientists use to discover new therapeutics. Register Now!
`
`TOOLS
`
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`
`Comment
`
`"Kadcyla is an antibodydrug conjugate representing a completely new way to treat
`HER2positive metastatic breast cancer, and it helped people in the EMILIA study
`live nearly six months longer," said Hal Barron, Roche's chief medical officer and
`head of global product development.
`
`Print
`
`Contact
`Author
`
`In early October Roche revealed that the armed antibody delivered a 32% reduction
`in the risk of death among patients in the pivotal Phase III study when compared to
`the standardofcare arm. The median overall survival rate for TDM1 patients hit
`an impressive 30.9 months, while patients taking a combination of Tykerb and
`Xeloda achieved a 25.1month OS rate.
`
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`
`J O I N 1 5 0 ,0 0 0 + I NS I D E R S
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`news monitor, covering biopharma deals, clinical
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`biotechnology news audience in the world. Sign up
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`POPULAR STORIES
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`MOST READ MOST SHARED
`
`UPDATED: GlaxoSmithKline rips into RTP R&D
`group, chopping 900plus jobs in global
`reorganization
`Buzz: Deep job cuts looming at GlaxoSmithKline's
`U.S. ops in RTP, Philly
`Amgen snags a lightningfast approval for its
`leukemia immunotherapy
`Sanofi hands over R&D site, $310M to Evotec in a
`crosscutting alliance
`Biogen barrels toward Alzheimer's Phase III after a
`promising early signal
`
`Reprint
`
`TDM1 has helped inspire a whole new wave of antibodydrug conjugates, many of
`which use technology from either ImmunoGen or Seattle Genetics.
`Roche/Genentech now has 25 ADCs in their pipeline, including 9 in clinical trials.
`And dozens more are in or near the clinic at other biopharma companies anxious
`http://www.fiercebiotech.com/story/rochegenentechsbreakthroughtdm1winsblockbusterokbreastcancer/20130222
`
`THE LIBRARY: EBOOK
`Whitepaper | Expert Advice: Designing
`Systems for Global Content Processes
`
`1/4
`
`IMMUNOGEN 2252, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Roche/Genentech's breakthrough TDM1 wins blockbuster OK for breast cancer FierceBiotech
`
`FierceBiotech
`
`Select another site Advertise Contact
`
`SEARCH
`
`Free Daily Biotech Industry Newsletter Get the latest on Biotech & Pharma Deals, Clinical Trials, FDA Decisions, and Key Regulatory Issues sent
`straight to your Inbox. Join over 150,000 biotech professionals who subscribe to FierceBiotech for FREE!
`Click here to see a sample.
`
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`
`EMAIL ADDRESS
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`NEWS TOPICS ANALYSIS FEATURES LIBRARY EVENTS JOBS MARKETPLACE
`
`Topics: Pipeline | R&D | Regulatory
`Roche/Genentech's breakthrough TDM1 wins
`blockbuster OK for breast cancer
`February 22, 2013 | By John Carroll
`
`SHARE
`
`The FDA today approved TDM1, a breakthrough antibody drug
`conjugate from Roche/Genentech widely expected to quickly
`become a new blockbuster treatment for breast cancer.
`
`71
`
`Tweet
`
`63
`
`Share
`
`0
`
`Like
`
`0
`
`Roche ($RHHBY) will market the newly approved drug as
`Kadcyla. Its partner ImmunoGen ($IMGN) stepped up with the
`ADC technology and stands to gain a small, singledigit royalty
`stream from the therapy.
`
`The drug will cost $9,800 a month,or about $94,000 for a 9.5
`month course of therapy. Analysts' peak sales projections for
`this drug have ranged from $2 billion to $5 billion a year.
`
`Hal Barron, CMO,
`head of global
`product
`development,
`Roche/Genentech
`
`Webinar: The Basics of Biotech 101, 201 & 301
`
`INDIVIDUAL SESSION: $129, FULL SERIES: $299
`This 3part webinar series is specifically geared toward the nonscience
`professional who needs to better understand industry terminology, science, techniques and
`issues. This series provides an overview of the science and technology used to enable
`discovery and the processes scientists use to discover new therapeutics. Register Now!
`
`TOOLS
`
`Sign up for our FREE newsletter for more news like this sent to your inbox!
`
`Comment
`
`"Kadcyla is an antibodydrug conjugate representing a completely new way to treat
`HER2positive metastatic breast cancer, and it helped people in the EMILIA study
`live nearly six months longer," said Hal Barron, Roche's chief medical officer and
`head of global product development.
`
`
`Contact
`Author
`
`In early October Roche revealed that the armed antibody delivered a 32% reduction
`in the risk of death among patients in the pivotal Phase III study when compared to
`the standardofcare arm. The median overall survival rate for TDM1 patients hit
`an impressive 30.9 months, while patients taking a combination of Tykerb and
`Xeloda achieved a 25.1month OS rate.
`
`FOLLOW US
`
`J O I N 1 5 0 ,0 0 0 + I NS I D E R S
`SIGN UP FOR OUR
`NEWSLETTER
`
`EMAIL ADDRESS
`
`FierceBiotech is the drug development industry's
`news monitor, covering biopharma deals, clinical
`trials, FDA decisions, and more. Subscribe to our free
`daily email and join the largest, most influential
`biotechnology news audience in the world. Sign up
`today!
`
`POPULAR STORIES
`
`MOST READ MOST SHARED
`
`UPDATED: GlaxoSmithKline rips into RTP R&D
`group, chopping 900plus jobs in global
`reorganization
`Buzz: Deep job cuts looming at GlaxoSmithKline's
`U.S. ops in RTP, Philly
`Amgen snags a lightningfast approval for its
`leukemia immunotherapy
`Sanofi hands over R&D site, $310M to Evotec in a
`crosscutting alliance
`Biogen barrels toward Alzheimer's Phase III after a
`promising early signal
`
`Reprint
`
`TDM1 has helped inspire a whole new wave of antibodydrug conjugates, many of
`which use technology from either ImmunoGen or Seattle Genetics.
`Roche/Genentech now has 25 ADCs in their pipeline, including 9 in clinical trials.
`And dozens more are in or near the clinic at other biopharma companies anxious
`http://www.fiercebiotech.com/story/rochegenentechsbreakthroughtdm1winsblockbusterokbreastcancer/20130222
`
`THE LIBRARY: EBOOK
`Whitepaper | Expert Advice: Designing
`Systems for Global Content Processes
`
`1/4
`
`IMMUNOGEN 2252, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`12/4/2014
`
`Roche/Genentech's breakthrough TDM1 wins blockbuster OK for breast cancer FierceBiotech
`to match TDM1's targeting capabilities with a powerful drug payload.
`Effective content harmonization
`requires a global system that can
`balance the needs of both the
`corporate office and satellite entities and
`partners. For companies considering content
`harmonization initiatives, this paper discusses
`best practices and the efficiency benefits they
`can expect from deploying a global system.
`Download now.
`
`"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease
`progression and prolong survival," said Dr. Richard Pazdur, director of the Office of
`Hematology and Oncology Products in the FDA's Center for Drug Evaluation and
`Research. "It is the fourth approved drug that targets the HER2 protein."
`
`Fewer people who received Kadcyla experienced severe side effects compared to
`those receiving standard therapy (40.8 percent vs. 57.0 percent), the FDA noted.
`But as expected a boxed warning will apply,noting that the drug can cause liver
`toxicity, heart toxicity and death. "The drug can also cause severe lifethreatening
`birth defects, and pregnancy status should be verified prior to starting Kadcyla
`treatment."
`
`"The biggest news in today's press release, given that approval was expected, was
`that the label allows for use in frontline HER2 positive metastatic breast cancer,"
`says Cowen's Simos Simeonidis in a note this morning. "This was not a major
`surprise, since EMILIA included about 12% frontline mBC patients (about 60 1st
`line mBC patients in the TDM1 arm of the EMILIA trial), but it was definitely not a
`given."
`
` here's the FDA's release
` get the release from Roche
`
`Special Reports: Hal Barron The 25 most influential people in biopharma today
`2013 | TDM1 Blockbuster buzz: 15 top therapies in latestage development
`
`Related Articles:
`Roche, ImmunoGen gain speedy review for TDM1 breast cancer breakthrough
`Bullish Roche talks targeted takeovers, showcases TDM1's prospects
`TDM1 survival rate wows as Roche pushes for megablockbuster approval
`Roche spotlights top blockbuster bets as it showcases R&D
`Promising TDM1 clears PhIII cancer study and marches on to the FDA
`
`Sign up for our free newsletter
`
`EMAIL ADDRESS
`
`Filed Under breast cancer, Genentech, Roche, TDM1
`
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`http://www.fiercebiotech.com/story/rochegenentechsbreakthroughtdm1winsblockbusterokbreastcancer/20130222
`
`2/4
`
`IMMUNOGEN 2252, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`12/4/2014
`
`Roche/Genentech's breakthrough TDM1 wins blockbuster OK for breast cancer FierceBiotech
`
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`IMMUNOGEN 2252, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`12/4/2014
`
`Roche/Genentech's breakthrough TDM1 wins blockbuster OK for breast cancer FierceBiotech
`
`http://www.fiercebiotech.com/story/rochegenentechsbreakthroughtdm1winsblockbusterokbreastcancer/20130222
`
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`Phigenix v. Immunogen
`IPR2014-00676
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