Kadcyla Approved for Treatment of HER2-positive Metastatic Breast Cancers

by U.S. Medicine

April 5, 2013

SAN FRANCISCO – The FDA has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin┬« (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Genentech to receive FDA approval for people with advanced cancers within the past two years. An antibody-drug conjugate (ADC), Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC. Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1, and it is the first Genentech ADC approved by the FDA.


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