IS T-DM1 THE NEXT BIG THING IN HER-2 POSITIVE BREAST CANCER, METASTATIC SETTING.

A conjugate drug associating Trastuzumab and DM1, a chemotherapy reported to have 500 times the effect of Taxol, was able to swing 6 month benefit of SURVIVAL as compared to a combination of Lapatinib and Xeloda in women with Metastatic HER-2 positive breast cancer.  Improving SURVIVAL is rarely achieved by most current recommended therapy.  This position this drug to be the next big thing in breast cancer responding to this characteristic.  The Oncology community is still waiting on the FDA to approve the drug last I checked.  T-DM-1 is a large molecule and must be engulfed by the cell by Endocytosis increasing delivery of DM-1 intracellularly, people have suggested this is a "smart Bomb" and Genentech had requested to FAST-TRACK the drug.   FDA did not comply, and some are filing petition to push this government institution to move forward!  Until the FDA approves, the drug is not available to the public!