A Triumph In Breast Cancer -- And Another Expensive Drug
`
`Page 1 of 3
`
`Matthew Herper (http://www.forbes.com/sites/matthewherper/) Forbes Staff
`I cover science and medicine, and believe this is biology's century.
`
`FOLLOW
`
`PHARMA & HEALTHCARE (/HEALTHCARE)
`
`2/22/2013 @ 10:09AM 6,693 views
`
`A Triumph In Breast Cancer --
`And Another Expensive Drug
`
`Comment Now
`
`Follow Comments
`
`When there was a bit of
`debate about whether the
`Food and Drug
`Administration should
`withdraw Avastin’s
`accelerated approval in
`breast cancer, I and
`others observed that the
`real complaint should have been that the FDA did
`not grant accelerated approval of another Roche
`drug, known as T-DM1.
`
`(http://www.daylife.com/image/05lm5jK73cblA?
`utm_source=zemanta&utm_medium=p&utm_content=05lm5jK73cblA&utm_campaign=z1)
`
`T-DM1 bound a tumor-killing drug, DM1, to Roche’s
`blockbuster drug Herceptin, or, as its generically
`known, trastuzumab. While Avastin had failed to
`show much efficacy in large studies, T-DM1 looked
`incredibly promising. But the FDA, while deciding
`correctly to yank Avastin’s breast cancer claim, also
`decided to wait until similar large trials had proved
`that T-DM1 was effective.
`
`Now those studies are complete and today the drug
`has been approved
`(http://www.gene.com/media/press-
`releases/14347/2013-02-22/fda-approves-
`genentechs-kadcyla-ado-tras/), with the name
`Kadcyla. Like Roche’s Herceptin, Kadcyla is only
`effective in patients whose tumors test positive for a
`molecular marker called HER2. In a clinical trial, it helped women survive 5.8
`months longer than did other approved drugs: Roche’s Xeloda or
`GlaxoSmithKline (http://www.forbes.com/companies/glaxosmithkline/)‘s
`Tykerb. There were fewer side effects.
`
`That’s great for patients. But this is one case where they probably should have
`had access sooner. And then there’s the matter of the drug’s price: $94,000 a
`year for the average patient. Genentech will provide the drug free to those who
`can’t pay.
`
`Genentech licenses technology used in Kadcyla from Immunogen.
`
`http://www.forbes.com/sites/matthewherper/2013/02/22/a-triumph-in-breast-cancer-and-an...
`
`7/25/2014
`
`IMMUNOGEN 2024, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`A Triumph In Breast Cancer -- And Another Expensive Drug
`
`Page 2 of 3
`
`A note on the name: Given the fact that the FDA
`tries to avoid lookalike drug names, how do we
`explain how similar Kadcyla is to Kalydeco, the
`cystic fibrosis drug from Vertex Pharmaceuticals?
`
`Below is a statement from Genentech spokesman Ed
`Lang:
`
`“ The monthly cost of Kadcyla in the United States
`
`(http://www.forbes.com/places/united-states/) is $9,800. The
`estimated cost of a course of Kadcyla is approximately $94,000.
`This is based on people taking Kadcyla for 9.6 months.
`
`When pricing Kadcyla, we considered a variety of factors
`including that cost of the combination of Tykerb and Xeloda
`(approximately $10,460 per month) which is the current standard treatment in this line of
`therapy and the comparator in the pivotal EMILIA study.
`
`In the EMILIA study, people receiving Kadcyla survived a median of 5.8 months longer
`compared to those taking Tykerb and Xeloda. Fewer people who received Kadcyla
`experienced Grade 3 or higher (severe) AEs than those who received Tykerb and Xeloda
`(43.1% vs 59.2%). No new safety signals were observed and AEs were consistent with those
`seen in previous studies.
`
`As part of this approval, Genentech will initiate patient assistance programs for people taking
`Kadcyla through Genentech Access Solutions. These programs help people who might not be
`able to afford this medicine. People who do not have health insurance, or who have reached
`the lifetime limit set by their insurance company, might qualify to receive Kadcyla free of
`charge.
`
`Comment Now
`
`Follow Comments
`
`PROMOTED STORIES
`
`Recommended by
`
`(http://www.businessinsider.com/investment-(http://www.businessinsider.com/motif-(http://www.healthcentral.com/heart-(http://www.learnvest.com/knowledge-
`
`
`
`investing-hardeep-walia-
`disease/cf/slideshows/how-
`center/your-ultimate-
`2012-6)
`to-manage-atrial-
`budget-guideline-the-
`Why you no longer
`fibrillation/avoid-caffeine-
`502030-rule/)
`want a human
`This Ex-Microsoft
`financial advisor
`Exec Will Not Sleep
`How To Budget Your
`(http://www.businessinsider.com/investment-
`Until He…
`Money: The 50/20/30
`How Caffeine Affects
`(http://www.businessinsider.com/motif-
`tips-for-the-99-2012-3)
`Rule
`Your Heart
`(http://www.learnvest.com/knowledge-
`investing-hardeep-walia-
`(http://www.healthcentral.com/heart-
`center/your-ultimate-
`2012-6)
`disease/cf/slideshows/how-
`budget-guideline-the-
`to-manage-atrial-
`502030-rule/)
`fibrillation/avoid-caffeine-
`and-other-stimulants/)
`
`Calculate how much
`you can spend
`
`(http://www.youtube.com/watch?(http://www.insidercarnews.com/5-(http://techpageone.dell.com/downtime/the-(http://www.shebudgets.com/lifestyle/entertainment/2
`
`
`
`exciting-cars-worth-waiting-
`vital-f1-job-you-never-see-
`celebrities-who-went-
`for/)
`on-tv/)
`5 Exciting Cars Worth
`The vital F1 job you
`Waiting For
`never see on TV
`(http://www.youtube.com/watch?
`(http://www.insidercarnews.com/5-(http://techpageone.dell.com/downtime/the-(http://www.shebudgets.com/lifestyle/entertainmen
`
`
`v=WBxAH4369sk)
`exciting-cars-worth-
`vital-f1-job-you-never-see-
`celebrities-who-went-
`waiting-for/)
`on-tv/)
`bankrupt/17203)
`
`Broke and Famous. 15
`Stars That Lost It All.
`
`http://www.forbes.com/sites/matthewherper/2013/02/22/a-triumph-in-breast-cancer-and-an...
`
`7/25/2014
`
`IMMUNOGEN 2024, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`A Triumph In Breast Cancer -- And Another Expensive Drug
`
`Page 3 of 3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`http://www.forbes.com/sites/matthewherper/2013/02/22/a-triumph-in-breast-cancer-and-an...
`
`7/25/2014
`
`IMMUNOGEN 2024, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`