T-DM1 Approval

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Trastuzumab emtansine (T-DM1 or trastuzumab-DM1) is an experimental immunoconjugate or antibody-drug conjugate (ADC) medication being tested by Genentech, part of the Roche Group, in collaboration with ImmunoGen, Inc. T-DMI is being researched for the treatment of HER2+ metastatic breast cancer. The antibody trastuzumab (Herceptin®) is a prescription medication used to treat HER2+ breast cancer. Emtansine (DM1) is a cytotoxin which is bound to trastuzumab.[1]

In 2012, several studies of T-DM1 were completed and the results released. These results will be considered during the overall FDA approval process. Other clinical trials are underway or recruiting.[2]

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Lab.jpg
Flickr: SLU Madrid Campus
Brand name for Trastuzumab emtansine (Trastuzumab-DM1)[1]
Manufacturer Roche in collaboration with Genentech and ImmunoGe, Inc.n[1]
Generic available? No
Uses If approved, T-DM1 will be used to treat HER2 positive breast cancer[1]
Common side effects Nausea and fatigue[3]
Major side effects Lowered blood platelet counts and elevation in liver function tests[4]
Warnings Trastuzumab can cause cardiomyopathy, cardiac death, or pulmonary toxicity. Trastuzumab can cause fetal harm when used during pregnancy.[5]
Disclaimer The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Selena Robinson
 
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Contents

T-DM1 Overview

Trastuzumab (Herceptin®) is an antibody used to treat HER2+ breast cancer. Initially approved by the FDA in 1998, it has also been tested and approved for use as chemotherapy in combination with other medications, including doxorubicin, cyclophosphamide, and paclitaxel to treat node-positive, HER2-overexpressing breast cancer, or cisplatin and a fluoropyrimidine to treat HER2-overexpressing metastatic gastric or gastroesophageal (GE) junction adenocarcinoma.[5] [6]

Emtansine (DM1) is a cytotoxin which is attached to trastuzumab to form a type of chemotherapy. Studies suggest that T-DM1 has at least two mechanisms of action and is more effective than trastuzumab alone.[4] [7] In addition to being used to treat HER2+ breast cancer, T-DM1 may also be effective against HER2+ gastric cancer.[1]

T-DM1 Approval Process

  • November 1, 2001: ImmunoGen announced that T-DM1 had been tested in mice with positive results.[8]
  • December 15, 2006: Positive Phase I study results were released.[9]
  • May 30, 2009: Encouraging Phase II clinical findings were released.[10]
  • August 27, 2010: The FDA refused accelerated approval for T-DM1. Phase III studies continued.[11]
  • June 3, 2012: Roche announced results from the Phase III EMILIA study showing improvement in progression-free survival time as well as overall survival in HER2+ patients taking T-DM1 compared to patients who received lapatinib plus Xeloda® (capecitabine). There was a 35 percent survival rate or decrease in the disease worsening in these patients. Based on these results, Roche and Genentech confirmed plans to submit applications for T-DM1 to the FDA and the European Medicines Agency (EMA) this year.[12]
  • August 27, 2012: ImmunoGen, Inc. and Roche announced updated results for the EMILIA Phase III trial, showing a significant improvement in progression-free and overall survival. Roche also submitted its trastuzumab emtansine marketing application to the FDA, with future plans to submit to the European Medicines Agency.[13]
  • November 07, 2012:FDA grants T-DM1 Priority Review for HER2-positive metastatic breast cancer[14]
  • February 26, 2013:Expected FDA action date[15]

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Also See: Herceptin Side Effects, Herceptin Coupons, Breast Cancer Awareness Month, Arimidex, Arimidex Coupons, Arimidex Side Effects, Avastin Side Effects, Marijuana and Cancer

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References

  1. 1.0 1.1 1.2 1.3 1.4 http://www.immunogen.com/pipeline/trastuzumab-emtansine/
  2. http://www.clinicaltrials.gov/ct2/results?intr=%22trastuzumab-MCC-DM1%22
  3. http://www.roche.com/media/media_releases/med-cor-2010-08-27.htm
  4. 4.0 4.1 http://ecancer.org/news/2888
  5. 5.0 5.1 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf
  6. http://www.cancer.gov/cancertopics/druginfo/fda-trastuzumab
  7. http://breast-cancer-research.com/content/13/2/R46
  8. http://investor.immunogen.com/releasedetail.cfm?ReleaseID=649639
  9. http://investor.immunogen.com/releasedetail.cfm?ReleaseID=648920
  10. http://investor.immunogen.com/releasedetail.cfm?releaseid=604707
  11. http://investor.immunogen.com/releasedetail.cfm?ReleaseID=604992
  12. http://www.roche.com/investors/ir_update/inv-update-2012-06-03b.htm
  13. http://investor.immunogen.com/releasedetail.cfm?ReleaseID=702345
  14. http://www.roche.com/investors/ir_update/inv-update-2012-11-07.htm
  15. http://www.breastcancer.org/research-news/20121114