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`New more effective treatment option for breast cancer patients
`approved by FDA
`Date:
`February 22, 2013
`Source:
`
`Rush University Medical Center
`
`Patients with HER2-positive breast cancer, a particularly aggressive form of breast cancer, now have a new,
`effective and less toxic therapeutic option.
`On Friday, Feb., 22, the Food and Drug Administration (FDA) approved the new treatment drug, Kadcyla
`(trastuzumab emtansine), also known as TDM-1, which combines Traztuzumab, also called Herceptin, with the
`powerful chemotherapy drug emtansine.
`The drug therapy is developed by Roche-owned Genentech, which funded the study.
`
`Results from clinical trials of the drug TDM-1, known as "Super Herceptin," showed that it was more effective and
`less toxic than the standard regimen for this type of tumor. The medication kept patients free of disease for longer
`than the standard chemotherapy regimen.
`
`Rush was one of only two medical centers in Illinois and a small number across the country studying the treatment.
`HER-2 positive breast cancer patients have been found to be positive for carrying a protein that promotes the growth
`of cancer cells. TDM-1 is taken directly to cells that have the HER2 protein on the membrane, such as the cancer
`cells, while sparing normal cells. This results in less toxicity from the chemotherapy drug.
`
`"TDM-1 works like the original drug Herceptin by hunting down and interfering with the cancer cells," said Dr. Melody
`Cobleigh, Director of the Comprehensive Breast Center at Rush and lead investigator of the TDM-1 clinical trials at
`Rush. "But this newer version, called TDM-1, is Herceptin with a chemotherapy drug attached. The combination
`delivers a one-two punch, seeking out the cancer cells and not only stopping growth but delivering the chemo right to
`the cell."
`
`"The tumor cell basically eats the TDM-1 and then, the TDM-1 gets released and destroys the tumor cell from the
`inside out," said Cobleigh.
`"The best part for patients is that it is very tolerable and does not have the debilitating side effects characteristic of
`other cancer drugs," said Cobleigh.
`With TDM-1, patients did not even lose their hair and experienced far fewer other side effects.
`
`"This really can have an impact on patient's lives," said Cobleigh.
`
`About 1,000 patients with HER-2 positive breast cancer were enrolled in the Phase III, randomized, multicenter, trial
`of TDM-1. One group of patients received TDM-1 and the other group received two standard chemotherapy drugs.
`The TDM-1 patients remained cancer-free for 9.6 months -- progression-free survival -- while the standard treatment
`group was cancer-free for 6.4 months. Progression-free survival is the time that elapses between the start of a
`treatment and the time the cancer gets worse.
`
`"This therapy has shown to be effective when other standards treatments have stopped working," said Cobleigh.
`"For men and women, the treatment gave them the opportunity to lead normal lives."
`
`For more information about the drug therapy being offered at Rush, please contact the Rush Comprehensive Breast
`Cancer Center at (312) 563-2325.
`Story Source:
`
`http://www.sciencedaily.com/releases/2013/02/130222120705.htm
`
`12/22/2014
`
`IMMUNOGEN 2255, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

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`Page 2 of 2
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`The above story is based on materials provided by Rush University Medical Center. Note: Materials may be edited
`for content and length.
`null
`Cite This Page:
`
`MLA
`
`APA
`
`Chicago
`
`Rush University Medical Center. "New more effective treatment option for breast cancer patients approved by
`FDA." ScienceDaily. ScienceDaily, 22 February 2013.
`<www.sciencedaily.com/releases/2013/02/130222120705.htm>.
`
`http://www.sciencedaily.com/releases/2013/02/130222120705.htm
`
`12/22/2014
`
`IMMUNOGEN 2255, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676