Genentech has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) for patients with HER2-positive breast cancer who have undergone and failed multiple prior HER2 targeted therapies.
The application stems from a single-arm, multi-center Phase II trial known as TDM4374g, which was designed to determine the efficacy of T-DM1 in 110 women with HER2-positive advanced breast cancer whose disease had proven to be resistant to at least two previous HER2-targeted therapies.
DRUG(S)
Trastuzumab-DM1 (T-DM1), an antibody-drug conjugate (ADC).
CANCER TYPE(S)
HER2-positive advanced breast cancer
HOW DOES IT WORK?
T-DM1 is what's called an armed antibody: trastuzumab and the chemotherapy DM1 are attached until they meet certain cancer cells in the body, at which time trastuzumab binds to the HER2-positive cells. Once absorbed, the DM1 is released, killing the cell.
WHERE WAS THIS RESEARCH FIRST PRESENTED?
The 2009 San Antonio Breast Cancer Symposium
By Ross Bonander
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