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New Breast Cancer Drug Approved by FDA -- HER-2 Positive Late Stage Breast Cancer

Ado-trastuzumab emtansine, an antibody-drug conjugate marketed as Kadcyla, has been approved by the FDA to treat HER2-positive late-stage (metastatic) breast cancer.  The drug — known as T-DM1 during clinical trials — is indicated for patients who didn't respond to treatment with the anti-HER2 agent trastuzumab plus chemotherapy.

Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein.

In a randomized trial of nearly 1000 patients, progression-free survival was longer with T-DM1 than with lapatinib plus capecitabine (9.6 vs. 6.4 months).  The approval has been "eagerly anticipated," says Journal Watch Oncology and Hematology Editor-in-Chief Dr. William Gradishar. He says he expects that the drug will become "the preferred treatment" in eligible patients.

Get the FDA Press Release:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340704.htm