FDA Blocks Life-Saving Drug, Herceptin T DM-1

We are Stage IV Cancer Survivors and supporters, battling an aggressive form of breast cancer known as Her2. Her2 is a mutated gene, first identified in the 1980’s. This mutated gene accounts for about 2/3rds of the most aggressive breast cancers. A drug that targets that gene, and shuts it off, Herceptin, was developed in the 1990’s. It cures many patients. However, some Her2 survivors seem to have other yet un-identified mutations that Herceptin alone cannot cure. Fast forward to 2010. The maker of Herceptin has succeeded in attaching a chemo directly onto Herceptin. It is called Herceptin TDM-1. Like a “heat- seeking missile” the chemo rides the Herceptin only to the mutated cells, and “blows them up.” This is a first of its kind, revolutionary drug. Some oncologists have described it as “a potential home run.” It has some of the best stats EVER for a cancer drug. And it has FEWER SIDE EFFECTS !
Yet this FDA blocked its Approval last September, 2010 ! This appears to be part of this FDA’s attempt to overhaul / obstruct the Accelerated Approval Program. Just as new, potential cures reach patients.
Please ask Dr. Sebelius, President Obama’s Secretary of Health and Human Services, to investigate this FDA decision. This decision is Costing Lives and causing Needless Suffering ! Please Speak Up !!!